Philips Healthcare Inc.

Complete recall history across all FDA and CPSC categories — 36 total recalls

Philips Healthcare 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 (36)

FDA medical device enforcement actions by Philips Healthcare Inc.

Date Product Reason Class
Aug 8, 2013 Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-... The mirror icon on the bottom of each image could be misinterpreted as a RIGH... Class II
Jul 8, 2013 Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.... IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signa... Class II
Jun 19, 2013 Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A,... The MRx may deliver a non-synchronized cardioversion shock resulting in the d... Class II
Jun 11, 2013 Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ra... The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply wit... Class II
Apr 8, 2013 HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M,... Device may fail to deliver defibrillation therapy in either Manual Defib or A... Class II
Mar 5, 2013 Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Se... If a customer creates customized trend scales in the trend review tile and th... Class II
Jan 28, 2013 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The He... Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinica... Class II
Jan 16, 2013 Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... Installation Acceptance Test Document (IATD) non compliant with regulations. ... Class II
Jan 16, 2013 Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Uni... The mirror icon on the bottom of each image could be misinterpreted as a RIGH... Class II
Jan 16, 2013 Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Nu... An inspection shows several IATDs (Installation Acceptance Test could not be ... Class II
Jan 16, 2013 Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... Installation Acceptance Test Document (IATD) non compliant with regulations I... Class II
Jan 16, 2013 Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032... An inspection of IATD (Installation Acceptance Test Document)IA SID (Source I... Class II
Jan 14, 2013 Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 ... VS2+ screen may lock up and stop monitoring during patient use Class II
Dec 13, 2012 Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70... Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not b... Class II
Nov 28, 2012 Mobile Diagnostic X-Ray System with Digital Panel When the operator moves an image to another view then the electronic marker m... Class II
Nov 9, 2012 Philips IntelliVue Information Center/Client and Philips IntelliVue Informati... Internal audio cable may have diminished retention force due to damaged conta... Class II
Oct 30, 2012 Philips Digital Diagnost Stationary radiographic system When the operator for a wall stand view selects an "image rotation" different... Class II
Oct 30, 2012 Philips Digital Diagnost Software Version R2.0.2 Product Usage: This syst... With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the ima... Class II
Oct 25, 2012 Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers... When the operator for a wall stand view selects an "image rotation" different... Class II
Sep 12, 2012 Philips Digital Diagnost with patient carriage Model: 712050 with serial nu... Hook does not securely hold the footplate in vertical position, causing the f... Class II
Sep 11, 2012 Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat... HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power ... Class II
Sep 6, 2012 Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single ... The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile ... Class II
Aug 15, 2012 Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ ... Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and ... Class II
Aug 14, 2012 Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary ... Creepage Distance between the two primary phases in the GEO Transformer is 4.... Class II
Jul 25, 2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... Essenta DR C-Arm may fall Class II
Jul 11, 2012 Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642... Inclination switch in the stand may have been mounted incorrectly, as a resul... Class II
Jul 11, 2012 Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 ... When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstructio... Class II
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M... HeartStart MRx Unexpected Pads/Paddles ECG Failure Class II
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M35... Therapy Cable Connection wear may lead to a malfunction in detection of defib... Class II
Jun 20, 2012 Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 ... Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 l... Class II
Jun 14, 2012 Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data... Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatt... Class II
May 22, 2012 Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 includ... With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into... Class II
May 21, 2012 Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 70... MultiDiagnost Eleva X--Ray system may have damage to System Cables from repea... Class II
May 11, 2012 Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system If a lead ruler is not positioned in the same plane as the anatomical image d... Class II
Oct 19, 2011 Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribu... When the system is switched off or when the tube arm is parked in the down po... Class II
Apr 5, 2010 Philips Healthcare Computed Tomography X-Ray System. These devices are who... Philips Healthcare discovered the customer was performing CTDI measurements ... 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.

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