Philips Ultrasound recalls
11 official recalls and safety alerts involving Philips Ultrasound since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Philips Ultrasound or the relevant agency.
- 2026-09-30
USPhilips Ultrasound, LLC recalls Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
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.
FDA · DevicePhilips Ultrasound, LLCWorldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA,…Official notice →- 2026-04-01
- US
Philips Ultrasound, Inc recalls Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2026-01-07
- US
Philips Ultrasound, LLC recalls Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232,…
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
FDA · DevicePhilips Ultrasound, LLCWorldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice → - 2025-12-10
- US
Philips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
FDA · DevicePhilips Ultrasound, LLCWorldwide US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2025-09-03
- US
Philips Ultrasound, Inc recalls TRANSDUCER L12-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- 2025-07-09
- US
Philips Ultrasound, Inc recalls Philips eL18-4 EMT Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
FDA · DevicePhilips Ultrasound, IncDomestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium,…Official notice → - 2024-05-15
- US
Philips Ultrasound, Inc. recalls 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300…
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…
FDA · DevicePhilips Ultrasound, Inc.Worldwide - US Nationwide distribution including in the states of CA, CO, CT,…Official notice → - 2023-11-15
- US
Philips Ultrasound, Inc. recalls Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
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.
FDA · DevicePhilips Ultrasound, Inc.US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS:…Official notice → - 2023-09-13
- US
Philips Ultrasound, Inc. recalls 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact…
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…
FDA · DevicePhilips Ultrasound, Inc.Worldwide - US Nationwide distribution including in the states of FL, MN, AZ,…Official notice → - 2021-10-27
- US
Philips Ultrasound Inc recalls EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
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…
FDA · DevicePhilips Ultrasound IncUS: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA.…Official notice → - 2021-10-13
- US
Philips Ultrasound Inc recalls Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
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.
FDA · DevicePhilips Ultrasound IncWorldwide distribution - US Nationwide distribution in the states of CA, MA,…Official notice →