Wayne, NJ, United States
Getinge Usa Sales Inc recalls
26 recalls recorded since 2018, most recently on 15 January 2025. 17 are listed as ongoing. Status and classification are as published by the FDA.
Recalls26
Ongoing (FDA)17
Terminated or completed9
Class I (FDA)6
Ongoing Class I Medical devices
- Recall started
- 15 January 2025
- Reason
- Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
- Distribution
- Domestic distribution to Kentucky and Connecticut.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1074-2025
- Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Ongoing Class II Medical devices
- Recall started
- 3 October 2024
- Reason
- Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bhutan, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Israel, Japan, Jordan, Korea, Republic Of Kuwait, "Macedonia, The Former Yugoslav Republic Of
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0462-2025, Z-0460-2025, Z-0458-2025, Z-0463-2025, Z-0456-2025, Z-0461-2025, Z-0457-2025, Z-0459-2025
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2
- MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2
Ongoing Class II Medical devices
- Recall started
- 29 May 2024
- Reason
- The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure.
- Distribution
- Domestic: KY, NC, NY, VA. International: Australia, Bulgaria, Croatia, Czech Republic, Denmark, France, Greece, Hong Kong, Ireland, Israel, Japan, Jordan, Kuwait, Mexico, New Zealand, Norway, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, United Arab Emirates, United Kin
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2271-2024, Z-2273-2024, Z-2272-2024
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
- ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
Ongoing Class I Medical devices
- Recall started
- 1 May 2024
- Reason
- Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
- Distribution
- Domestic: CA, CO, IN, MO, OR, VA, WA. International: Aruba, Australia, Austria, Belgium, Bolivia, Bosnia-Herzegovina, Brazil, Bulgaria, Chile, China, Costa Rica, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jo
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1877-2024
- Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
Ongoing Class II Medical devices
- Recall started
- 11 December 2023
- Reason
- Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0990-2024, Z-0987-2024, Z-0991-2024, Z-0988-2024, Z-0989-2024
- Flow-c Anesthesia System, model 6887700
- Flow-i C20 Anesthesia System, model 6677200
- Flow-e Anesthesia System, model 6887900
- Flow-i C30 Anesthesia System, model 6677300
- Flow-i C40 Anesthesia System, model 6677400
Ongoing Class II Medical devices
- Recall started
- 8 November 2023
- Reason
- A potential for a light system to fall in the operating room.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0763-2024, Z-0770-2024, Z-0760-2024, Z-0759-2024, Z-0757-2024, Z-0761-2024, Z-0758-2024, Z-0765-2024, Z-0769-2024, Z-0764-2024, Z-0768-2024, Z-0771-2024 and 3 more
- Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A,
- Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD5
- Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A,
- Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDLCA209008A, LCA 10 -
- Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - A
- Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - A
- Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP
- Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
- and 7 more product lines
Ongoing Class II Medical devices
- Recall started
- 6 September 2023
- Reason
- Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0036-2024
- Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Ongoing Class I Medical devices
- Recall started
- 22 December 2022
- Reason
- Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
- Distribution
- US nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0961-2023, Z-0960-2023, Z-0959-2023
- Getinge Flow-e Anesthesia System, Part No. 6887900
- Getinge Flow-c Anesthesia System, Part No. 6887700
- Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Ongoing Class II Medical devices
- Recall started
- 7 November 2022
- Reason
- The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.
- Distribution
- US Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0422-2023
- Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Ongoing Class II Medical devices
- Recall started
- 14 October 2022
- Reason
- The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN. The countries of Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Bulgaria (BG), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0239-2023
- Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Ongoing Class II Medical devices
- Recall started
- 21 July 2022
- Reason
- Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Ar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1568-2022
- Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
Ongoing Class I Medical devices
- Recall started
- 20 July 2022
- Reason
- Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.
- Distribution
- Worldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech Republic, Italy, Belgium, Estonia, Greece, Finland, Portugal, Netherlands, Romania, Austria, Slovakia, Lithuania, Ireland, Latvia, Norway, Sweden, Malaysia, China, Singapore, Taiwan, Iceland, Slovenia, Hungary, Bulgaria, De
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1560-2022
- Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Ongoing Class II Medical devices
- Recall started
- 6 May 2022
- Reason
- Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1308-2022
- VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A V
Terminated Class I Medical devices
- Recall started
- 2 May 2022
- Terminated
- 6 August 2024
- Reason
- Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
- Distribution
- US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1278-2022, Z-1279-2022
- Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
- Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Ongoing Class II Medical devices
- Recall started
- 13 April 2022
- Reason
- Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
- Distribution
- US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1249-2022, Z-1248-2022
- Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
- Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
Ongoing Class II Medical devices
- Recall started
- 1 April 2022
- Reason
- Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
- Distribution
- Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Kuwait,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1078-2022
- Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Ongoing Class I Medical devices
- Recall started
- 9 December 2021
- Reason
- A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of VA and MO. The countries of Austria, Bahrain, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Estonia, Iraq, Israel, Italy, Japan, Kenya, Malaysia, Mexico, Morocco, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Port
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0468-2022
- Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457
Ongoing Class II Medical devices
- Recall started
- 13 November 2019
- Reason
- Sterile barrier system may be compromised
- Distribution
- Nationwide Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0677-2020
- Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Terminated Class II Medical devices
- Recall started
- 22 August 2019
- Terminated
- 27 April 2020
- Reason
- Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
- Distribution
- US state of NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2559-2019
- The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed
Terminated Class II Medical devices
- Recall started
- 22 July 2019
- Terminated
- 26 May 2020
- Reason
- Reversed expiration and manufacturing date on the label
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2433-2019
- Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
Terminated Class II Medical devices
- Recall started
- 5 June 2019
- Terminated
- 24 April 2020
- Reason
- The monitor displays an error message . The error message states "internal error restart or service".
- Distribution
- US Nationwide distribution in the states of MD, OK, NY,FL, SC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2077-2019
- PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessar
Terminated Class III Medical devices
- Recall started
- 20 March 2019
- Terminated
- 8 April 2020
- Reason
- Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
- Distribution
- Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1221-2019
- Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electro
Terminated Class II Medical devices
- Recall started
- 8 January 2019
- Terminated
- 3 June 2020
- Reason
- The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.
- Distribution
- The products were distributed to the following US states: AZ and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0987-2019, Z-0988-2019, Z-0989-2019, Z-0990-2019
- Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical
- Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association w
- Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in associat
- Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with s
Terminated Class II Medical devices
- Recall started
- 7 February 2018
- Terminated
- 2 September 2021
- Reason
- The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Est
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1349-2018
- VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during s
Terminated Class II Medical devices
- Recall started
- 3 January 2018
- Terminated
- 3 July 2018
- Reason
- A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
- Distribution
- FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1172-2018
- HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Terminated Class II Medical devices
- Recall started
- 16 November 2017
- Terminated
- 21 July 2021
- Reason
- Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.
- Distribution
- U.S. and Gov. accts.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1927-2018
- ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
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.