FDA recall record · openFDA
Philips Ultrasound, Inc
105 FDA recalls on record (2023–2025) — 105 device. 105 still ongoing.
0
Class I (most serious)
25
Class II
80
Class III
105
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
To provide clarification and labelling to define the useful life of ultrasound transducers in the field. 80
Ultrasound transducer devices were refurbished beyond their useful life. 21
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed ima 2
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to ch 1
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE conn 1
Recalls
Philips eL18-4 EMT Transducer. Class II 2025-05-28 Philips C9-5EC Transducer. Class II 2025-05-28 Philips eL18-4 Transducer. Class II 2025-05-28 Philips C5-2 Transducer. Class II 2025-05-28 Philips L12-3 Transducer. Class II 2025-05-28 Philips X6-1 Transducer. Class II 2025-05-28 Philips X8-2t Transducer. Class II 2025-05-28 Philips V6-2 Transducer. Class II 2025-05-28 Philips S5-1 Transducer. Class II 2025-05-28 Philips S7-2 Transducer. Class II 2025-05-28 Philips 3D9-3v Transducer. Class II 2025-05-28 Philips X7-2t Transducer. Class II 2025-05-28 Philips X5-1 Transducer. Class II 2025-05-28 Philips S8-3t Transducer. Class II 2025-05-28 Philips XL14-3 Transducer. Class II 2025-05-28 Philips C5-1 Transducer. Class II 2025-05-28 Philips L12-4 Transducer. Class II 2025-05-28 Philips VL13-5 Transducer. Class II 2025-05-28 Philips L8-4 Transducer. Class II 2025-05-28 Philips L9-3 Transducer. Class II 2025-05-28 Philips S7-3t Transducer. Class II 2025-05-28 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Pr Class II 2024-03-23 Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 Class II 2023-10-09 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2 Class II 2023-06-30 Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 7 Class II 2023-10-09 TRANSDUCER L12-5 Transducer Probe Class III 2025-07-03 C6-2 Transducer Probe Class III 2025-07-03 L12-5 38mm Transducer Probe Class III 2025-07-03 C8-4v Transducer Probe Class III 2025-07-03 L9-3 Transducer Probe Class III 2025-07-03 X7-2 Transducer Probe Class III 2025-07-03 Philips S5-2 Ultrasound Transducer Class III 2025-09-05 S9-2 Transducer Probe Class III 2025-07-03 C8-5 Transducer Probe Class III 2025-07-03 mC7-2 Transducer Probe Class III 2025-07-03 C5-2 Lumify Transducer Probe Class III 2025-07-03 X6-1 Transducer Probe Class III 2025-07-03 C9-3v Transducer Probe Class III 2025-07-03 L12-4 Transducer Probe Class III 2025-07-03 BP10-5ec Transducer Probe Class III 2025-07-03 SCNHD LA L7-4 HDI Transducer Probe Class III 2025-07-03 L8-4 Transducer Probe Class III 2025-07-03 7.5MHZ Endo Transducer Probe Class III 2025-07-03 L10-4LAP Transducer Probe Class III 2025-07-03 C10-4ec Transducer Probe Class III 2025-07-03 X5-1 Transducer Probe Class III 2025-07-03 C8-4v Transducer Probe Class III 2025-07-03 VL13-5 Transducer Probe Class III 2025-07-03 S4-1 Lumify Transducer Probe Class III 2025-07-03 S4-2 Transducer Probe Class III 2025-07-03 OMNI II TEE Transducer Probe Class III 2025-07-03 C9-2 Transducer Probe Class III 2025-07-03 Philips S4-1 Ultrasound Transducer Class III 2025-09-05 3D9-3v Transducer Probe Class III 2025-07-03 L18-5 Transducer Probe Class III 2025-07-03 D2cwc Transducer Probe Class III 2025-07-03 mL26-8 Transducer Probe Class III 2025-07-03 C6-3 Transducer Probe Class III 2025-07-03 eL18-4 Transducer Probe Class III 2025-07-03 Philips X3-1 Ultrasound Transducer Class III 2025-09-05 Philips OMNI II TEE Ultrasound Transducer Class III 2025-09-05 mC12-3 Transducer Probe Class III 2025-07-03 L15-7io Transducer Probe Class III 2025-07-03 X5-1c Transducer Probe Class III 2025-07-03 L12-4 Lumify Transducer Probe Class III 2025-07-03 S7-3t Transducer Probe Class III 2025-07-03 S5-2 Transducer Probe Class III 2025-07-03 3D6-2 Transducer Probe Class III 2025-07-03 C9-4v Transducer Probe Class III 2025-07-03 S3-1 Transducer Probe Class III 2025-07-03 S8-3t Transducer Probe Class III 2025-07-03 Philips L17-5 Ultrasound Transducer Class III 2025-09-05 D5cwc Transducer Probe Class III 2025-07-03 Transducer C10-3v Transducer Probe Class III 2025-07-03 X11-4t Transducer Probe Class III 2025-07-03 L12-3 Transducer Probe Class III 2025-07-03 Mini Multi TEE Transducer Probe Class III 2025-07-03 S4-1 Transducer Probe Class III 2025-07-03 c5-1 Transducer Probe Class III 2025-07-03 V6-2 Transducer Probe Class III 2025-07-03 Philips Mini Multi TEE Ultrasound Transducer Class III 2025-09-05 C9-4 Transducer Probe Class III 2025-07-03 Philips OMNI III TEE Ultrasound Transducer Class III 2025-09-05 L12-5 50 Transducer Probe Class III 2025-07-03 V9-2 Transducer Probe Class III 2025-07-03 XL14-3 Transducer Probe Class III 2025-07-03 X8-2t Transducer Probe Class III 2025-07-03 C9-3io Transducer Probe Class III 2025-07-03 L11-3 Transducer Probe Class III 2025-07-03 OMNI III TEE Transducer Probe Class III 2025-07-03 D2TCD Transducer Probe Class III 2025-07-03 Philips 3D6-2 Ultrasound Transducer Class III 2025-09-05 Philips X7-2 Ultrasound Transducer Class III 2025-09-05 C5-2 Transducer Probe Class III 2025-07-03 L15-7IO TRANSDUCER Transducer Probe Class III 2025-07-03 Philips C9-4 Ultrasound Transducer Class III 2025-09-05 X7-2t Transducer Probe Class III 2025-07-03 Philips L12-5 Ultrasound Transducer Class III 2025-09-05 L17-5 Transducer Probe Class III 2025-07-03 C10-3v Transducer Probe Class III 2025-07-03 C9-5ec Transducer Probe Class III 2025-07-03 S8-3 Transducer Probe Class III 2025-07-03 S12-4 Transducer Probe Class III 2025-07-03 S7-2t Transducer Probe Class III 2025-07-03 X3-1 Transducer Probe Class III 2025-07-03
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.