Philips Medical Systems, Inc.

Complete recall history across all FDA and CPSC categories — 65 total recalls

Philips Medical Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (65)

FDA medical device enforcement actions by Philips Medical Systems, Inc.. Showing most recent 50.

Date Product Reason Class
Apr 23, 2015 Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The ... A problem (the dose computed in planning mode is calculated incorrectly ) has... Class II
Feb 9, 2015 Philips Healthcare DuraDiagnost X- Ray The system is designed to emit a beep upon termination of an exposure. Howev... Class II
Feb 9, 2015 Philips Healthcare DigitalDiagnost System X-Ray The system is designed to emit a beep upon termination of an exposure. Howev... Class II
Feb 3, 2015 Philips Healthcare Allure BiPlane Series: Model 722013 Allura X... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare Xper cardio systems Model : 722123 Product Usage: T... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare Xper vascular system Model : 722124 Product Usage: ... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage:... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usa... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usa... Monitor Ceiling Suspension system may fall Class II
Feb 3, 2015 Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usag... Monitor Ceiling Suspension system may fall Class II
Jan 23, 2015 Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Mode... Improper installation of Tube arm, and Wall stand may cause it to fall down, ... Class II
Dec 23, 2014 HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, ... MRx monitor/defibrillator could reboot at an indeterminate time, potentially ... Class II
Dec 19, 2014 Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are i... Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled with... Class II
Nov 20, 2014 Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upg... VCG battery ignited in a VCG unit when recharging. Class II
Nov 19, 2014 Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliV... Philips has discovered that the Instructions for Use (IFU) for the IntelliVue... Class II
Nov 19, 2014 Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A 1. Device will perform the weekly automated tests hourly, which could cause t... Class II
Nov 19, 2014 Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, ... MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port ass... Class II
Nov 19, 2014 HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J,... Device may malfunction, which could cause therapy to be delayed, disabled, or... Class II
Oct 10, 2014 Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) an... Mold on gel filled Gel-E and Squishon products Class I
Oct 3, 2014 Philips Avalon Monitors with software revision J.30.58: Model Product F... Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/s... Class II
Oct 3, 2014 Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Mo... Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/s... Class II
Sep 24, 2014 Foot Switches used with the following systems: Philips Allura Xper Systems; 7... Loss of key image functionality due to a bent pedal of the Footswitch. Class II
Sep 24, 2014 Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ... Loss of key image functionality due to a bent pedal of the Footswitch. Class II
Aug 21, 2014 Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions... When a fused series of a sagittal, coronal or radial multi station scan is ge... Class II
Aug 19, 2014 Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Mod... The hook does not securely hold the footplate in vertical position. Therefore... Class II
Aug 19, 2014 Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Mo... The hook does not securely hold the footplate in vertical position. Therefore... Class II
Aug 8, 2014 Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Philips had discovered through a field service testing where a device failed... Class II
Aug 7, 2014 Philips IntelliSpace ECG Management System, with software option C61 needed ... Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ... Class II
Jul 31, 2014 Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: Th... It was discovered that a software defect may result in the scanner not termi... Class II
Jul 8, 2014 Philips Medical Systems Allura Xper FD20C Radiological Imaging with software ... Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test... Class II
Jul 8, 2014 Philips Medical Systems Allura Xper FD20C with software version R8.2.O Syste... Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test... Class II
Jun 13, 2014 Ingenia 1.5T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2... Class II
Jun 13, 2014 Ingenia 1.5T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2... Class II
Jun 13, 2014 Ingenia 3.0T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2... Class II
Jun 13, 2014 Ingenia 3.0T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2... Class II
Jun 6, 2014 Philips Medical System Allura Xper X-Ray Angiographic In certain circumstances, a software error can lead to a situation where the ... Class II
May 22, 2014 IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue I... IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or... Class II
May 15, 2014 Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T pro... Ingenia customers have experienced clamping of the foot under the central col... Class II
May 15, 2014 Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T prod... Ingenia customers have experienced clamping of the foot under the central col... Class II
May 5, 2014 All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R... In spine clinical workflows, cross reference lines may be used to determine t... Class II
Apr 8, 2014 Intended for both adult and pediatric patients for taking diagnostic radiogra... In special cases, during the start-up of the current model of MobileDiagnost ... Class II
Apr 4, 2014 Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitor... The risk of battery failure increases with age, when a battery remains in use... Class II
Apr 2, 2014 Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software appli... Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may hav... Class II
Apr 2, 2014 Philips HeartStart XL+ Defibrillator/Monitor with system software version B.... Software communication failure may occur on the HeartStart XL+ locking the us... Class II
Mar 31, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automati... A component on the HeartStart XL+ Therapy Board could malfunction potentially... Class II
Mar 17, 2014 Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50... The footboard of Patient support for stitching can be fixed in upper position... Class II
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J... ECG trunk cable and connector block of the MRx could be susceptible to accele... Class II
Feb 18, 2014 HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J... Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power... Class II

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Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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