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All Recalls

Every Philips Medical Systems, Inc. Recall

Sorted by most recent. Click any recall for full details.

46 recalls
High RiskFDA
Philips Medical Systems, Inc.
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professiona...
Medical Devices·4 affected·Apr 23, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare DigitalDiagnost System X-Ray
Diagnostic Devices·54 affected·Feb 9, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovasc...
Medical Implants·3 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovas...
Medical Implants·22 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovas...
Medical Implants·1 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allu...
Medical Implants·9 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascul...
Medical Implants·8 affected·Feb 3, 2015
High RiskFDA
Philips Medical Systems, Inc.
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Diagnostic Devices·71 affected·Jan 23, 2015
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage...
Cardiac Devices·75,693 affected·Dec 23, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 86...
Medical Devices·10,013 affected·Dec 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeab...
Medical Devices·79 affected·Nov 20, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Prod...
Cardiac Devices·74,499 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for...
Cardiac Devices·27,918 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Cardiac Devices·1,553 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneo...
Medical Devices·86 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT;...
Medical Devices·7,587 affected·Oct 3, 2014
High RiskFDA
Philips Medical Systems, Inc.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva i...
Respiratory Devices·168 affected·Sep 24, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diag...
Diagnostic Devices·307 affected·Aug 21, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Diagnostic Devices·1,517 affected·Aug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Diagnostic Devices·260 affected·Aug 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Medical Devices·0 affected·Aug 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography ...
Medical Devices·16 affected·Jul 31, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended fo...
Diagnostic Devices·2 affected·Jul 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 3.0T, magnetic resonance imaging system.
Medical Devices·18 affected·Jun 13, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 3.0T R5, magnetic resonance imaging system.
Medical Devices·21 affected·Jun 13, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 1.5T, magnetic resonance imaging system.
Medical Devices·24 affected·Jun 13, 2014
High RiskFDA
Philips Medical Systems, Inc.
Ingenia 1.5T R5, magnetic resonance imaging system.
Medical Devices·33 affected·Jun 13, 2014
High RiskFDA
Philips Medical Systems, Inc.
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Medical Devices·42,600 affected·May 22, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Ad...
Diagnostic Devices·5 affected·May 15, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height A...
Diagnostic Devices·420 affected·May 15, 2014
High RiskFDA
Philips Medical Systems, Inc.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnost...
Diagnostic Devices·317 affected·May 5, 2014
High RiskFDA
Philips Medical Systems, Inc.
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, ...
Diagnostic Devices·247 affected·Apr 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, an...
Medical Devices·188,520 affected·Apr 4, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic extern...
Cardiac Devices·9,872 affected·Apr 2, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, dist...
Medical Devices·373 affected·Apr 2, 2014
High RiskFDA
Philips Medical Systems, Inc.
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
Diagnostic Devices·985 affected·Mar 17, 2014
High RiskFDA
Philips Medical Systems, Inc.
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia...
Cardiac Devices·220 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for ...
Cardiac Devices·6,583 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for ...
Cardiac Devices·39,128 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Cardiac Devices·3,541 affected·Feb 18, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
Cardiac Devices·58,466 affected·Feb 4, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified ...
Cardiac Devices·7,157 affected·Jan 24, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray syste...
Medical Devices·424 affected·Dec 5, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips Multi Diagnost Eleva II
Diagnostic Devices·238 affected·Oct 14, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx ...
Cardiac Devices·93 affected·Jun 7, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart...
Cardiac Devices·64,972 affected·Apr 10, 2013