Waukesha, WI, United States
GE Medical Systems, LLC recalls
29 recalls recorded since 2018, most recently on 5 June 2026. 24 are listed as ongoing. Status and classification are as published by the FDA.
Recalls29
Ongoing (FDA)24
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 June 2026
- Reason
- GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
- Distribution
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2726-2026, Z-2727-2026, Z-2728-2026
- Optima XR200amx, Mobile Digital-Ready Radiographic System
- Optima XR220amx, Mobile Digital-Ready Radiographic System
- Optima XR240amx, Mobile Digital Radiographic System
Ongoing Class II Medical devices
- Recall started
- 1 May 2026
- Reason
- GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2477-2026, Z-2475-2026, Z-2476-2026
- Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
- Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
- Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
Ongoing Class II Medical devices
- Recall started
- 20 April 2026
- Reason
- GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2314-2026, Z-2317-2026, Z-2318-2026, Z-2315-2026, Z-2316-2026
- Allia IGS 3 Pulse angiographic X-ray system
- Allia IGS Pulse angiographic X-ray system
- Allia Moveo angiographic X-ray system
- Allia IGS 5 Pulse angiographic X-ray system
- Allia IGS 7 Pulse angiographic X-ray system
Ongoing Class II Medical devices
- Recall started
- 26 March 2026
- Reason
- GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2153-2026, Z-2149-2026, Z-2155-2026, Z-2151-2026, Z-2154-2026, Z-2152-2026, Z-2150-2026
- Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
- Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
- Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
- Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
- Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
- Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
- Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
Ongoing Class II Medical devices
- Recall started
- 3 February 2026
- Reason
- There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1590-2026
- Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Ongoing Class II Medical devices
- Recall started
- 30 January 2026
- Reason
- There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1570-2026, Z-1571-2026, Z-1569-2026
- Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-
- Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088
- Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-0
Ongoing Class II Medical devices
- Recall started
- 24 October 2025
- Reason
- Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
- Distribution
- U.S. and OUS.
- Initiated
- FDA Mandated
- Recall number
- Z-0875-2026
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Ongoing Class II Medical devices
- Recall started
- 18 September 2025
- Reason
- The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0156-2026, Z-0157-2026, Z-0155-2026
- LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
- LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
- LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Ongoing Class II Medical devices
- Recall started
- 22 August 2025
- Reason
- If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign/Global) to countries of: Australia, Austria, Bahrain, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Philipp
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0231-2026
- MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
Ongoing Class II Medical devices
- Recall started
- 2 July 2025
- Reason
- GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
- Distribution
- US Nationwide distribution.
- Initiated
- FDA Mandated
- Recall numbers
- Z-2342-2025, Z-2341-2025
- GE HealthCare OEC 9900 Elite C-arm Systems.
- GE HealthCare OEC 9800.
Ongoing Class II Medical devices
- Recall started
- 20 June 2025
- Reason
- GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2299-2025, Z-2314-2025, Z-2313-2025, Z-2300-2025, Z-2306-2025, Z-2301-2025, Z-2316-2025, Z-2310-2025, Z-2319-2025, Z-2309-2025, Z-2317-2025, Z-2311-2025 and 10 more
- GE Signa Artist, Nuclear Magnetic Resonance Imaging System
- GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
- GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
- GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
- GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
- GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
- GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
- GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
- and 14 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 May 2025
- Reason
- GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
- Distribution
- Worldwide distribution - US Nationwide and the country of China.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2130-2025, Z-2131-2025, Z-2133-2025, Z-2132-2025
- SIGNA Architect
- SIGNA Architect AIR
- SIGNA PET/MR
- Discovery MR750w 3.0T
Ongoing Class II Medical devices
- Recall started
- 21 March 2025
- Reason
- OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- Distribution
- US and OUS
- Initiated
- FDA Mandated
- Recall numbers
- Z-1819-2025, Z-1820-2025
- OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical
- OEC 3D
Ongoing Class II Medical devices
- Recall started
- 6 March 2025
- Reason
- The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1555-2025, Z-1556-2025
- Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Numb
- Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for Chi
Ongoing Class II Medical devices
- Recall started
- 18 February 2025
- Reason
- GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1297-2025, Z-1301-2025, Z-1302-2025, Z-1303-2025, Z-1299-2025, Z-1300-2025, Z-1298-2025
- GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
- GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
- GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
- GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
- GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
- GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
- GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Ongoing Class II Medical devices
- Recall started
- 28 January 2025
- Reason
- The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland,
- Initiated
- FDA Mandated
- Recall numbers
- Z-1046-2025, Z-1043-2025, Z-1045-2025, Z-1044-2025
- Optima XR646 HD. X-Ray imaging system.
- Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
- Discovery XR656 HD. X-Ray imaging system.
- Discovery XR656HD. X-Ray imaging system.
Ongoing Class II Medical devices
- Recall started
- 6 December 2024
- Reason
- There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, TX and the countries of Australia, China, Czech Republic, France, Italy, Netherlands, Qatar, Singapore, UAE, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0918-2025
- Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure a
Ongoing Class II Medical devices
- Recall started
- 25 November 2024
- Reason
- GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0812-2025, Z-0811-2025, Z-0813-2025
- GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
- GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
- GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
Ongoing Class II Medical devices
- Recall started
- 18 November 2024
- Reason
- Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0815-2025, Z-0818-2025, Z-0814-2025, Z-0817-2025, Z-0816-2025
- Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
- Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
- Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-00
- Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
- Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Ongoing Class II Medical devices
- Recall started
- 28 October 2024
- Reason
- Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0519-2025, Z-0517-2025, Z-0518-2025, Z-0520-2025
- SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
- Discovery MR750w 3.0T, whole body magnetic resonance scanner
- SIGNA Architect, Nuclear Magnetic Resonance Imaging System
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Ongoing Class II Medical devices
- Recall started
- 14 June 2024
- Reason
- GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2473-2024, Z-2459-2024, Z-2475-2024, Z-2466-2024, Z-2467-2024, Z-2470-2024, Z-2478-2024, Z-2481-2024, Z-2474-2024, Z-2476-2024, Z-2468-2024, Z-2472-2024 and 14 more
- SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
- SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
- Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
- SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
- and 18 more product lines
Ongoing Class II Medical devices
- Recall started
- 16 November 2022
- Reason
- GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0729-2023, Z-0732-2023, Z-0730-2023, Z-0731-2023, Z-0733-2023
- B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
- B125M Patient Monitor, REF 6160000-004-XXXXXX
- B125P Patient Monitor (with E-module slot option), REF 6160000-002
- B105M Patient Monitor, REF 6160000-003
- B125M Patient Monitor, REF 6160000-005-XXXXXXX
Ongoing Class II Medical devices
- Recall started
- 10 November 2022
- Reason
- Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0753-2023, Z-0754-2023, Z-0752-2023, Z-0756-2023, Z-0757-2023, Z-0759-2023, Z-0755-2023, Z-0758-2023
- Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); P
- Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac
- Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); P
- Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Org
- Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Pe
- Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac
- Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac
- Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (
Ongoing Class II Medical devices
- Recall started
- 28 October 2022
- Reason
- There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
- Distribution
- Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0722-2023, Z-0721-2023
- Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
- Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Terminated Class II Medical devices
- Recall started
- 3 October 2018
- Terminated
- 27 May 2022
- Reason
- A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
- Distribution
- Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0236-2019
- SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for u
Terminated Class II Medical devices
- Recall started
- 7 June 2018
- Terminated
- 18 June 2020
- Reason
- The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.
- Distribution
- Worldwide Distribution: US (nationwide) including states of:: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and countries of: Algeria, Argentina,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0110-2019, Z-0111-2019, Z-0112-2019
- GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD,
- GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIG
- GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *
Terminated Class II Medical devices
- Recall started
- 6 June 2018
- Terminated
- 27 May 2022
- Reason
- GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
- Distribution
- Worldwide Distribution - US Nationwide and in the states of AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, US, UT, VA, WA, WI, and WY. and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bel
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3279-2018
- Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499
Terminated Class II Medical devices
- Recall started
- 30 March 2018
- Terminated
- 29 March 2024
- Reason
- There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table.
- Distribution
- US Nationwide distribution to AZ, CA, CO, FL, IL, KS, MI, MN, NY, OH, PA, TX, UT, VA, WI. Worldwide distribution to Austria, Brazil, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, South Africa, Turkey, Turkey, United Arab Emirates, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2527-2018
- MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic reson
Terminated Class II Medical devices
- Recall started
- 7 December 2015
- Terminated
- 8 November 2018
- Reason
- GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
- Distribution
- Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWIT
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0201-2019, Z-0553-2016
- GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
- GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.