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Philips Ultrasound Recalls
134 recalls on record · July 30, 2014 to April 1, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S7-3t Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S7-2 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S5-1 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L9-3 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L8-4 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L12-4 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L12-3 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips eL18-4 EMT Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips eL18-4 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips C9-5EC Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips C5-2 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips C5-1 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips 3D9-3v Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
May 15, 2024Medical DevicesFDA
Philips Ultrasound, Inc. recalls 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Pr
Hazard: 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
November 15, 2023Medical DevicesFDA
Philips Ultrasound, Inc. recalls Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Hazard: 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.
November 15, 2023Medical DevicesFDA
Philips Ultrasound, Inc. recalls Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 7
Hazard: 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.
September 13, 2023Medical DevicesFDA
Philips Ultrasound, Inc. recalls 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2
Hazard: 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.
October 27, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Hazard: 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.
October 13, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Hazard: 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.
October 13, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Hazard: 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.
September 29, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affini
Hazard: Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
September 29, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795
Hazard: Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
August 25, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Hazard: 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.
February 10, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ
Hazard: 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.
February 10, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPI
Hazard: 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.
January 20, 2021Medical DevicesFDA
Philips Ultrasound Inc recalls All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx
Hazard: 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.
May 13, 2020Medical DevicesFDA
Philips Ultrasound Inc recalls Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage:
Hazard: 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
May 13, 2020Medical DevicesFDA
Philips Ultrasound Inc recalls Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ
Hazard: 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
May 13, 2020Medical DevicesFDA
Philips Ultrasound Inc recalls Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - P
Hazard: 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
May 13, 2020Medical DevicesFDA
Philips Ultrasound Inc recalls Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti
Hazard: 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