Philips Ultrasound, Inc.
Bothell, WA
This page shows every FDA and USDA recall linked to Philips Ultrasound, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
36
Total Recalls
2004
First Recall
2024
Most Recent
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W...
Nov 9, 2023
· Device
Completed
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Nov 9, 2023
· Device
Completed
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850;...
Sep 6, 2023
· Device
Completed
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Sep 21, 2021
· Device
Terminated
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797...
Aug 19, 2021
· Device
Terminated
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797...
Aug 19, 2021
· Device
Terminated
Affiniti Diagnostic Ultrasound Systems:
Software Versions 5.0, 5.0.1 and 5.0.2
Models:
Affiniti 30 7951...
Aug 6, 2021
· Device
Completed
EPIQ Diagnostic Ultrasound Systems:
Software Versions 5.0, 5.0.1 and 5.0.2
Models:
EPIQ 5 - 795120
EPI...
Aug 6, 2021
· Device
Completed
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EP...
Jul 22, 2021
· Device
Completed
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPI...
Dec 24, 2020
· Device
Terminated
Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ...
Dec 16, 2020
· Device
Terminated
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W...
Oct 27, 2020
· Device
Terminated
Transducer S7-3t
UDI (01)00884838061439
REF 989605406772
Can be used with: CX50, EPIQ 7, Affiniti 50 and Aff...
Aug 30, 2019
· Device
Terminated
Transducer S7-3t
UDI (01)00884838067530
REF 989605439232
Used as accessory with: iE33, HD11 Ultrasound Syste...
Aug 30, 2019
· Device
Terminated
Transducer S8-3t
UDI (01)00884838067523
REF 989605420183
Can be used with: iE33 Utrasound System - Product U...
Aug 30, 2019
· Device
Terminated
Transducer S8-3t
UDI (01)00884838073524
REF 989605431171
Can be used as accessory with: EPIQ 7, Affiniti 70,...
Aug 30, 2019
· Device
Terminated
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ...
Aug 6, 2019
· Device
Terminated
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W.
Diagnosti...
Mar 28, 2016
· Device
Terminated
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216
Part Number: 989605449841 with 453561845331 (so...
Jan 6, 2016
· Device
Terminated
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 9...
Jun 15, 2015
· Device
Terminated
EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPI...
May 19, 2015
· Device
Terminated
EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPI...
May 19, 2015
· Device
Terminated
EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 7...
May 5, 2015
· Device
Terminated
EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 7...
May 5, 2015
· Device
Terminated
EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug...
Dec 16, 2014
· Device
Terminated
Additional devices identified in new FSN MA-FCO 83000190:
QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins i...
Dec 16, 2014
· Device
Terminated
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station,...
Dec 16, 2014
· Device
Terminated
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug...
Dec 16, 2014
· Device
Terminated
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designe...
Jul 23, 2014
· Device
Terminated
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed...
Jul 23, 2014
· Device
Terminated
iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrason...
Feb 17, 2007
· Device
Terminated
Optimus 30
Nov 8, 2005
· Device
Terminated
Envisor, M2540 Diagnostic Ultrasound System
Jun 22, 2005
· Device
Terminated
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01)...
Jun 3, 2005
· Device
Terminated
HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
Nov 5, 2004
· Device
Terminated