Reedsville, PA, United States
Philips Ultrasound, Inc recalls
18 recalls recorded since 2018, most recently on 7 August 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls18
Ongoing (FDA)6
Terminated or completed12
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 August 2026
- Reason
- Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA, KS, MD, MN, NJ, NY, OH, PA, SC, TN, TX, VA, WA, WI and the countries of Austria, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lithuania, Netherlands, Norway, Philippines, Poland, Romania, Slovenia, South Korea,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3249-2026
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Ongoing Class II Medical devices
- Recall started
- 31 October 2025
- Reason
- Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
- Distribution
- Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Arm
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0883-2026
- Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Ongoing Class III Medical devices
- Recall started
- 5 September 2025
- Reason
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1626-2026, Z-1625-2026, Z-1627-2026, Z-1623-2026, Z-1621-2026, Z-1622-2026, Z-1624-2026, Z-1618-2026, Z-1628-2026, Z-1619-2026, Z-1620-2026
- Philips S5-2 Ultrasound Transducer
- Philips S4-1 Ultrasound Transducer
- Philips X3-1 Ultrasound Transducer
- Philips OMNI II TEE Ultrasound Transducer
- Philips L17-5 Ultrasound Transducer
- Philips Mini Multi TEE Ultrasound Transducer
- Philips OMNI III TEE Ultrasound Transducer
- Philips 3D6-2 Ultrasound Transducer
- and 3 more product lines
Ongoing Class III Medical devices
- Recall started
- 3 July 2025
- Reason
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2402-2025, Z-2355-2025, Z-2375-2025, Z-2358-2025, Z-2382-2025, Z-2411-2025, Z-2399-2025, Z-2359-2025, Z-2384-2025, Z-2354-2025, Z-2410-2025, Z-2362-2025 and 57 more
- TRANSDUCER L12-5 Transducer Probe
- C6-2 Transducer Probe
- L12-5 38mm Transducer Probe
- C8-4v Transducer Probe
- L9-3 Transducer Probe
- X7-2 Transducer Probe
- S9-2 Transducer Probe
- C8-5 Transducer Probe
- and 61 more product lines
Ongoing Class II Medical devices
- Recall started
- 28 May 2025
- Reason
- Ultrasound transducer devices were refurbished beyond their useful life.
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2053-2025, Z-2051-2025, Z-2052-2025, Z-2050-2025, Z-2054-2025, Z-2065-2025, Z-2067-2025, Z-2062-2025, Z-2058-2025, Z-2059-2025, Z-2048-2025, Z-2066-2025 and 9 more
- Philips eL18-4 EMT Transducer.
- Philips C9-5EC Transducer.
- Philips eL18-4 Transducer.
- Philips C5-2 Transducer.
- Philips L12-3 Transducer.
- Philips X6-1 Transducer.
- Philips X8-2t Transducer.
- Philips V6-2 Transducer.
- and 13 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 March 2024
- Reason
- Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
- Distribution
- Worldwide - US Nationwide distribution including in the states of CA, CO, CT, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NH, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA and the countries of Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1757-2024
- 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come
Completed Class II Medical devices
- Recall started
- 9 October 2023
- Reason
- Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
- Distribution
- US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0284-2024, Z-0283-2024
- Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
- Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (m
Completed Class II Medical devices
- Recall started
- 30 June 2023
- Reason
- Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
- Distribution
- Worldwide - US Nationwide distribution including in the states of FL, MN, AZ, NC, CA, MO, OH, WV, AL, NH, IN, IL, VT, PA, NY, NE, TX, WI, MI, KY, NV, MA, SD, LA, CO, TN, AK, GA, WA, UT, NM, ME, AR, SC and the countries of Italy, China, Netherlands, New Zealand, Hungary, Australia, France, Thailand,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2517-2023
- 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Completed Class II Medical devices
- Recall started
- 14 July 2022
- Reason
- Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
- Distribution
- Worldwide - US Nationwide distribution in the 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, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1007-2026
- Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Terminated Class II Medical devices
- Recall started
- 21 September 2021
- Terminated
- 12 April 2024
- Reason
- Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.
- Distribution
- US: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA. OUS: Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Republic of Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0123-2022
- EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Terminated Class II Medical devices
- Recall started
- 19 August 2021
- Terminated
- 6 September 2024
- Reason
- Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0071-2022, Z-0070-2022
- Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
- Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Completed Class II Medical devices
- Recall started
- 6 August 2021
- Reason
- Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countrie
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2484-2021, Z-2483-2021
- Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
- EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ
Completed Class II Medical devices
- Recall started
- 22 July 2021
- Reason
- Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL, UT, CA, CO, WA, MS, NC, NV, GA, LA, VA, SC, NE, TN, HI, OR, ID, MI, OH, IN, IL, OK, TX, PA, NJ, CT, NY, DE, SD, WI, VT, MN, KS, MO, KY, MA, NH, IA, MT, NM, ME, AZ, AR, AL, WY, ND, AK, MD, RI, WV, DC, VI and the countr
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2306-2021
- EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Terminated Class II Medical devices
- Recall started
- 24 December 2020
- Terminated
- 21 March 2023
- Reason
- Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break off.
- Distribution
- Worldwide distribution - US Nationwide, Puerto Rico, and Virgin Islands. O.U.S.: AE - United Arab Emirates AL - Albania AM - Armenia AR - Argentina AT - Austria AU - Australia AZ - Azerbaijan BA - Bosnia BD - Bangladesh BE - Belgium BG - Bulgaria BH - Bahrain BN - Brunei BO - Bolivi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0947-2021
- Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image
Terminated Class II Medical devices
- Recall started
- 16 December 2020
- Terminated
- 15 March 2023
- Reason
- The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.
- Distribution
- US - AL, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE,NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI and WV OUS- Austria, Australia, Belgium, Canada, Chezh Republic, Croatia, Denmark, Egypt, Finland, France, Hong Kong, Indonesia, India, Ireland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0944-2021
- Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPI
Terminated Class II Medical devices
- Recall started
- 27 October 2020
- Terminated
- 19 April 2023
- Reason
- The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the 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 WY. The countries
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0864-2021
- All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761
Terminated Class II Medical devices
- Recall started
- 30 August 2019
- Terminated
- 27 November 2024
- Reason
- The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1843-2020, Z-1841-2020, Z-1844-2020, Z-1842-2020
- Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analys
- Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the
- Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophage
- Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly
Terminated Class II Medical devices
- Recall started
- 29 April 2019
- Terminated
- 4 August 2022
- Reason
- There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of the device.
- Distribution
- Worldwide Distribution - US Nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, De
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2199-2019
- Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended us
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.