FDA Device Recalls

Recalls / Firms / Philips Medical Systems, Inc.

Philips Medical Systems, Inc.

66 FDA device recalls on record.

DateClassProductReason
2015-04-23Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software al
2015-02-09Philips Healthcare DigitalDiagnost System X-Ray
2015-02-09Philips Healthcare DuraDiagnost X- Ray
2015-02-03Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series
2015-02-03Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is
2015-02-03Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series i
2015-02-03Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series
2015-02-03Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is in
2015-02-03Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722
2015-02-03Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is
2015-02-03Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series
2015-02-03Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura
2015-01-23Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
2014-12-23HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M
2014-12-19Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue:
2014-11-20Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Num
2014-11-19Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M
2014-11-19Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
2014-11-19Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for
2014-11-19HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536
2014-10-10Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. Th
2014-10-03Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A
2014-10-03Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A;
2014-09-24Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C,
2014-09-24Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 70803
2014-08-21Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with
2014-08-19Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
2014-08-19Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
2014-08-08Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
2014-08-07Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the
2014-07-31Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brillianc
2014-07-08Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System
2014-07-08Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The All
2014-06-13Ingenia 3.0T, magnetic resonance imaging system.
2014-06-13Ingenia 1.5T R5, magnetic resonance imaging system.
2014-06-13Ingenia 1.5T, magnetic resonance imaging system.
2014-06-13Ingenia 3.0T R5, magnetic resonance imaging system.
2014-06-06Philips Medical System Allura Xper X-Ray Angiographic
2014-05-22IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (P
2014-05-15Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage:
2014-05-15Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage:
2014-05-05All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of softw
2014-04-08Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the s
2014-04-04Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is use
2014-04-02Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 install
2014-04-02Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for
2014-03-31Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator
2014-03-17Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/8
2014-02-18HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J,
2014-02-18HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is
2014-02-18Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M
2014-02-18Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08
2014-02-18M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the ter
2014-02-18Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,
2014-02-14Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartS
2014-02-04Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M
2014-01-24Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use i
2013-12-10Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for
2013-12-05Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a mult
2013-10-30Easy Diagnost Eleva Universal Fluoroscopic applications
2013-10-23BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrat
2013-10-14Philips Multi Diagnost Eleva II
2013-10-14Philips Multi Diagnost Eleva with FlatDetector
2013-06-07Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Mo
2013-04-10Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536
2003-01-23Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.