PlainRecalls

Philips Ultrasound, Inc.

85 recalls on record · Latest: Sep 3, 2025

FDA Devices Low Sep 3, 2025

C9-4 Transducer Probe

FDA Devices Moderate Jul 9, 2025

Philips eL18-4 EMT Transducer.

FDA Devices Moderate Jul 9, 2025

Philips C9-5EC Transducer.

FDA Devices Moderate Jul 9, 2025

Philips eL18-4 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips C5-2 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips L12-3 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips X6-1 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips X8-2t Transducer.

FDA Devices Moderate Jul 9, 2025

Philips V6-2 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips S5-1 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips S7-2 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips 3D9-3v Transducer.

FDA Devices Moderate Jul 9, 2025

Philips X7-2t Transducer.

FDA Devices Moderate Jul 9, 2025

Philips X5-1 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips S8-3t Transducer.

FDA Devices Moderate Jul 9, 2025

Philips XL14-3 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips C5-1 Transducer.

FDA Devices Moderate Jul 9, 2025

Philips L12-4 Transducer.

FDA Devices Moderate Nov 15, 2023

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

FDA Devices Moderate Sep 13, 2023

3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000

FDA Devices Moderate Oct 27, 2021

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

FDA Devices Moderate Oct 13, 2021

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

FDA Devices Moderate Sep 29, 2021

Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795…

FDA Devices Moderate Feb 10, 2021

Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIA…

FDA Devices Moderate Feb 10, 2021

Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Us…

FDA Devices Moderate Jan 20, 2021

All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, A…

FDA Devices Moderate May 13, 2020

Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound syst…

FDA Devices Moderate May 13, 2020

Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Prod…

FDA Devices Moderate May 13, 2020

Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imagin…

FDA Devices Moderate Aug 14, 2019

Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affini…

FDA Devices Moderate Apr 20, 2016

EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound im…

FDA Devices Moderate May 13, 2015

EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 9896053867…

FDA Devices Moderate Dec 24, 2014

Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera softwa…

FDA Devices Moderate Dec 24, 2014

EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPI…

FDA Devices Moderate Jul 30, 2014

QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acqui…