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 |
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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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