FDA Device Recalls

Recalls / Firms / Philips Ultrasound, Inc

Philips Ultrasound, Inc

137 FDA device recalls on record.

DateClassProductReason
2025-09-05Philips Mini Multi TEE Ultrasound Transducer
2025-09-05Philips X3-1 Ultrasound Transducer
2025-09-05Philips S4-1 Ultrasound Transducer
2025-09-05Philips L12-5 Ultrasound Transducer
2025-09-05Philips OMNI II TEE Ultrasound Transducer
2025-09-05Philips S5-2 Ultrasound Transducer
2025-09-05Philips C9-4 Ultrasound Transducer
2025-09-05Philips OMNI III TEE Ultrasound Transducer
2025-09-05Philips X7-2 Ultrasound Transducer
2025-09-05Philips 3D6-2 Ultrasound Transducer
2025-09-05Philips L17-5 Ultrasound Transducer
2025-07-03Mini Multi TEE Transducer Probe
2025-07-03D2TCD Transducer Probe
2025-07-03OMNI III TEE Transducer Probe
2025-07-03C9-3v Transducer Probe
2025-07-03C10-3v Transducer Probe
2025-07-03C8-4v Transducer Probe
2025-07-03BP10-5ec Transducer Probe
2025-07-03C9-5ec Transducer Probe
2025-07-03SCNHD LA L7-4 HDI Transducer Probe
2025-07-03C9-3io Transducer Probe
2025-07-03D5cwc Transducer Probe
2025-07-03S7-3t Transducer Probe
2025-07-03C8-5 Transducer Probe
2025-07-03C10-4ec Transducer Probe
2025-07-03S8-3t Transducer Probe
2025-07-03S8-3 Transducer Probe
2025-07-03X7-2t Transducer Probe
2025-07-03C5-2 Transducer Probe
2025-07-03X8-2t Transducer Probe
2025-07-03C9-2 Transducer Probe
2025-07-03X5-1 Transducer Probe
2025-07-03S9-2 Transducer Probe
2025-07-03mC7-2 Transducer Probe
2025-07-03C6-2 Transducer Probe
2025-07-03XL14-3 Transducer Probe
2025-07-03L15-7IO TRANSDUCER Transducer Probe
2025-07-03L12-5 38mm Transducer Probe
2025-07-03VL13-5 Transducer Probe
2025-07-03C9-4v Transducer Probe
2025-07-03X6-1 Transducer Probe
2025-07-033D9-3v Transducer Probe
2025-07-03S4-2 Transducer Probe
2025-07-03X7-2 Transducer Probe
2025-07-03TRANSDUCER L12-5 Transducer Probe
2025-07-03L12-4 Transducer Probe
2025-07-03C5-2 Lumify Transducer Probe
2025-07-03mC12-3 Transducer Probe
2025-07-03L15-7io Transducer Probe
2025-07-03S3-1 Transducer Probe
2025-07-03S12-4 Transducer Probe
2025-07-03L11-3 Transducer Probe
2025-07-03S5-2 Transducer Probe
2025-07-03mL26-8 Transducer Probe
2025-07-03C6-3 Transducer Probe
2025-07-03L12-3 Transducer Probe
2025-07-03C8-4v Transducer Probe
2025-07-037.5MHZ Endo Transducer Probe
2025-07-03eL18-4 Transducer Probe
2025-07-03L10-4LAP Transducer Probe
2025-07-03S4-1 Lumify Transducer Probe
2025-07-03L9-3 Transducer Probe
2025-07-03L12-5 50 Transducer Probe
2025-07-03V9-2 Transducer Probe
2025-07-03S7-2t Transducer Probe
2025-07-03D2cwc Transducer Probe
2025-07-03Transducer C10-3v Transducer Probe
2025-07-03L12-4 Lumify Transducer Probe
2025-07-03C9-4 Transducer Probe
2025-07-03L18-5 Transducer Probe
2025-07-03L8-4 Transducer Probe
2025-07-03c5-1 Transducer Probe
2025-07-03V6-2 Transducer Probe
2025-07-03OMNI II TEE Transducer Probe
2025-07-033D6-2 Transducer Probe
2025-07-03S4-1 Transducer Probe
2025-07-03X5-1c Transducer Probe
2025-07-03X3-1 Transducer Probe
2025-07-03X11-4t Transducer Probe
2025-07-03L17-5 Transducer Probe
2025-05-28Philips XL14-3 Transducer.
2025-05-28Philips L8-4 Transducer.
2025-05-28Philips C9-5EC Transducer.
2025-05-28Philips V6-2 Transducer.
2025-05-28Philips L9-3 Transducer.
2025-05-28Philips X5-1 Transducer.
2025-05-28Philips L12-4 Transducer.
2025-05-28Philips S7-3t Transducer.
2025-05-28Philips X8-2t Transducer.
2025-05-28Philips eL18-4 Transducer.
2025-05-28Philips X6-1 Transducer.
2025-05-28Philips S7-2 Transducer.
2025-05-28Philips X7-2t Transducer.
2025-05-28Philips L12-3 Transducer.
2025-05-28Philips VL13-5 Transducer.
2025-05-28Philips eL18-4 EMT Transducer.
2025-05-28Philips C5-2 Transducer.
2025-05-28Philips S5-1 Transducer.
2025-05-28Philips 3D9-3v Transducer.
2025-05-28Philips C5-1 Transducer.
2025-05-28Philips S8-3t Transducer.
2024-03-235000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5
2023-10-09Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201)
2023-10-09Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
2023-06-303D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; Cle
2021-09-21EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
2021-08-19Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500
2021-08-19Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500
2021-08-06Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30
2021-08-06EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120
2021-07-22EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EP
2020-12-24Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EP
2020-12-16Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPI
2020-10-27All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7
2019-08-30Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultras
2019-08-30Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System -
2019-08-30Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti
2019-08-30Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Af
2019-04-29Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPI
2016-03-28EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W.
2015-12-09Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561
2015-05-15Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part
2015-04-14EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EP
2015-04-14EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EP
2015-04-10EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog
2015-04-10EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog
2014-11-05EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or
2014-11-05Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ
2014-11-05Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model:
2014-11-05EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or
2014-07-09QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package
2014-07-09QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application packa
2006-11-02iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo
2005-05-13Envisor, M2540 Diagnostic Ultrasound System
2005-05-06Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (850
2005-02-24Optimus 30
2004-09-10HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).