Philips Ultrasound, Inc recalls
Every recall we track for Philips Ultrasound, Inc — 119 in all, from 2019–2025 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Philips Ultrasound, Inc more than tripled in 2025 (101, up from 1 in 2024). 1% rated “stop using now”.
All FDA recall records for Philips Ultrasound, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 4 | 1 | 0 | 5 |
| 2020 | 0 | 1 | 2 | 0 | 3 |
| 2021 | 0 | 3 | 3 | 0 | 6 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 2 | 0 | 3 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 1 | 0 | 99 | 1 | 101 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Philips Ultrasound, Inc recalls
What to do if you have a recalled Philips Ultrasound, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Philips Ultrasound, Inc recalls
15 shown- Lower riskMedical device
Philips Ultrasound, Inc recalls Philips S5-2 Ultrasound Transducer
Philips recalls S5-2 ultrasound transducers for labeling clarity on useful life. This update helps users understand expected service duration without safety risks.
PhilipsSep 5, 2025 - Lower riskMedical device
Philips Ultrasound, Inc recalls TRANSDUCER L12-5 Transducer Probe
Philips recalls L12-5 Transducer Probe model 989605408174 for labeling clarity on useful life in field use. No immediate safety risk.
PhilipsJul 3, 2025 - Lower riskMedical device
Philips Ultrasound, Inc recalls Philips eL18-4 EMT Transducer.
Philips recalls eL18-4 EMT Transducers refurbished beyond useful life. Affected units may have reduced safety. Contact Philips for details.
PhilipsMay 28, 2025 - Use cautionMedical device
Philips Ultrasound, Inc. recalls 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and
Philips recalls 5000 Compact Series ultrasound systems with Deluxe/Premium Carts that may cause patient burns due to temperature issues when transducers are misconfigured.
PhilipsMar 23, 2024 - Lower riskMedical device
Philips Ultrasound, Inc. recalls Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Philips recalls Affiniti 70 ultrasound systems with software version 10.0 that may show delayed images instead of real-time. Affected units have specific serial numbers and model numbers. Contact Philips for remedy.
PhilipsOct 9, 2023 - Use cautionMedical device
Philips Ultrasound, Inc. recalls 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15;
Philips recalls 3D9-3v transducers for EPIQ Elite and other ultrasound systems due to risk of tissue damage and electric shock from parts separating.
PhilipsJun 30, 2023 - Lower riskMedical device
Philips Ultrasound Inc recalls EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Philips recalls EPIQ CVxi ultrasound systems with software versions 6.0, 7.0, 7.0.3 due to potential treatment delays from EchoNavigator errors. Affected units may require system restarts during certain procedures.
PhilipsSep 21, 2021 - Use cautionMedical device
Philips Ultrasound Inc recalls Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Philips recalls Sparq diagnostic ultrasound systems with battery data issues causing intermittent shutdowns. Affected units have specific serial numbers. Contact Philips for details.
PhilipsAug 19, 2021 - Lower riskMedical device
Philips Ultrasound Inc recalls Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30
Philips recalls Affiniti Diagnostic Ultrasound Systems with software versions 5.0, 5.0.1, and 5.0.2 due to intermittent lock-ups during exams. Affected models include Affiniti 30, 50, and 70 series with specific serial numbers. No action is required for users but they should check their software version.
PhilipsAug 6, 2021 - Use cautionMedical device
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
Philips recalls EPIQ Elite and other ultrasound systems due to swivel lock failure that may cause musculoskeletal injuries during patient or user movement.
PhilipsJul 22, 2021 - Use cautionMedical device
Philips Ultrasound Inc recalls Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W,
Philips recalls EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi ultrasound systems due to risk of control panel arm assembly failure from missing or loose screws under pressure.
PhilipsDec 24, 2020 - Lower riskMedical device
Philips Ultrasound Inc recalls Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx &
Philips recalls EPIQ Elite, 5G, 5C, 7G, 7C, CVx & CVxi ultrasound systems due to Image Boost feature causing inaccurate blood flow visualization in certain transducers.
PhilipsDec 16, 2020 - Lower riskMedical device
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
Philips recalls EPIQ and Affiniti ultrasound systems with certain software versions due to potential incorrect patient data display and saving. Affected models include EPIQ 5G, EPIQ 7G, Affiniti 30, 50, and 70. No immediate action required but check software versions.
PhilipsOct 27, 2020 - Use cautionMedical device
Philips Ultrasound Inc recalls Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5,
Philips recalls S8-3t transducers for potential patient injury due to incorrect temperature measurement during transesophageal echocardiography (TEE) scans.
PhilipsAug 30, 2019 - Lower riskMedical device
Philips Ultrasound Inc recalls Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC
Philips recalls EPIQ and Affiniti ultrasound systems with software version 4.0 due to potential patient folder mix-ups during editing. Affected models include EPIQ 5G, EPIC 5C, and others. No immediate action needed but software update recommended.
PhilipsApr 29, 2019
Philips Ultrasound, Inc recall questions
How many recalls has Philips Ultrasound, Inc had?
119 recalls from Philips Ultrasound, Inc are on record with U.S. safety agencies, from 2019–2025.
What is the most recent Philips Ultrasound, Inc recall?
Philips Ultrasound, Inc recalls Philips S5-2 Ultrasound Transducer, dated Sep 5, 2025. Every Philips Ultrasound, Inc recall is listed on this page, newest first.
Why are Philips Ultrasound, Inc products recalled?
The most common reasons on record: Ultrasound transducer devices were refurbished beyond their useful life. (21).
What should I do if I have a recalled Philips Ultrasound, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Philips Ultrasound, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.