Philips Medical Systems, Inc.
Andover, MA
This page shows every FDA and USDA recall linked to Philips Medical Systems, 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.
65
Total Recalls
2013
First Recall
2015
Most Recent
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue:
866023 Int...
Dec 4, 2015
· Device
Terminated
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi...
Nov 23, 2015
· Device
Terminated
Philips HeartStart MRx Monitor/Defibrillator
Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5
The Hear...
Nov 10, 2015
· Device
Terminated
HeartStart MRx monitor/defibrillator
Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5...
Nov 5, 2015
· Device
Terminated
Philips HeartStart MRx Monitor/Defibrillators
Models: M3535A and M3536A
Nov 3, 2015
· Device
Terminated
Pinnacle3 Software Version 10.0, Model 459800200841.
Product Usage:
The Pinnacle 3 RTP software allows quali...
May 21, 2015
· Device
Terminated
Philips Healthcare DigitalDiagnost System X-Ray
May 19, 2015
· Device
Terminated
Philips Healthcare DuraDiagnost X- Ray
May 19, 2015
· Device
Terminated
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065...
Mar 20, 2015
· Device
Terminated
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic
Models: 712210, 712211
Mar 6, 2015
· Device
Terminated
Philips Medical System Allura Xper X-Ray Angiographic
Mar 2, 2015
· Device
Terminated
Philips Multi Diagnost Eleva II
Feb 26, 2015
· Device
Terminated
Philips Multi Diagnost Eleva with FlatDetector
Feb 26, 2015
· Device
Terminated
Philips Healthcare INTEGRIS vascular System
Model : 722122
Product Usage:
The Allura Xper series is intende...
Feb 3, 2015
· Device
Terminated
Philips Healthcare INTEGRIS cardio system
Model : 722121
Product Usage:
The Allura Xper series is intended...
Feb 3, 2015
· Device
Terminated
Philips Healthcare Allure BiPlane Series:
Model
722013 Allura Xper FD20 BIPLANE R7.6
722013 Allura...
Feb 3, 2015
· Device
Terminated
Philips Healthcare Xper vascular systems R7.6
Model : 722134
Product Usage:
The Allura Xper series is intend...
Feb 3, 2015
· Device
Terminated
Philips Healthcare Xper vascular system
Model : 722124
Product Usage:
The Allura Xper series is intended f...
Feb 3, 2015
· Device
Terminated
Philips Healthcare Xper cardio systems R7.6
Model : 722133
Product Usage:
The Allura Xper series is intended...
Feb 3, 2015
· Device
Terminated
Philips Healthcare Allura Xper Series:
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD21...
Feb 3, 2015
· Device
Terminated
Philips Healthcare Xper cardio systems
Model : 722123
Product Usage:
The Allura Xper series is intended for...
Feb 3, 2015
· Device
Terminated
Philips Healthcare INTEGRIS H5000F/Allura 9F
Model : 722017
Product Usage:
The Allura Xper series is intend...
Feb 3, 2015
· Device
Terminated
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous.
The IntelliVue TcG10 is a device for the measur...
Jan 16, 2015
· Device
Terminated
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M...
Jan 13, 2015
· Device
Terminated
Philips Brilliance iCT Computed Tomography X-Ray System
Product Usage:
The Brilliance iCT/Brilliance iCT SP i...
Dec 16, 2014
· Device
Terminated
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spin...
Dec 16, 2014
· Device
Terminated
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small),
92025-C (Medium) and Squishon 2 91033-2.
The products...
Dec 16, 2014
· Device
Terminated
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an...
Dec 12, 2014
· Device
Terminated
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 7220...
Nov 7, 2014
· Device
Terminated
Philips Medical Systems Allura Xper FD20C with software version R8.2.O
System Code: 722035.
The Allura Xper F...
Nov 7, 2014
· Device
Terminated
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19.
Model Product
MP5 M8105A;
MP5SC M8...
Oct 21, 2014
· Device
Terminated
Philips Avalon Monitors with software revision J.30.58:
Model Product
FM20 M2702A ;
FM30 M2703A ;
FM50 M...
Oct 21, 2014
· Device
Terminated
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Oct 9, 2014
· Device
Terminated
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038
This Phi...
Sep 24, 2014
· Device
Terminated
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Al...
Sep 24, 2014
· Device
Terminated
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton S...
Aug 21, 2014
· Device
Terminated
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Aug 19, 2014
· Device
Terminated
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Aug 19, 2014
· Device
Terminated
Ingenia 3.0T, magnetic resonance imaging system.
Jun 24, 2014
· Device
Terminated
Ingenia 1.5T, magnetic resonance imaging system.
Jun 24, 2014
· Device
Terminated
Ingenia 1.5T R5, magnetic resonance imaging system.
Jun 24, 2014
· Device
Terminated
Ingenia 3.0T R5, magnetic resonance imaging system.
Jun 24, 2014
· Device
Terminated
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products)
Product Usage: Diagnosti...
Jun 18, 2014
· Device
Terminated
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products)
Product Usage: Diagnostic...
Jun 18, 2014
· Device
Terminated
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 8...
Jun 10, 2014
· Device
Terminated
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for moni...
May 16, 2014
· Device
Terminated
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indi...
May 5, 2014
· Device
Terminated
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software
application that is used for receiving,...
Apr 24, 2014
· Device
Terminated
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Apr 24, 2014
· Device
Terminated
Philips HeartStart XL+ Defibrillator/Monitor
Model number: 861290, automatic external defibrillator.
Apr 9, 2014
· Device
Terminated