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Philips Medical Systems, Inc.

52 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by th recall (Z-0374-2016)Philips Medical Systems, Inc.2015-12-04
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5 recall (Z-0325-2016)Philips Medical Systems, Inc.2015-11-23
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536 recall (Z-0262-2016)Philips Medical Systems, Inc.2015-11-10
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536 recall (Z-0219-2016)Philips Medical Systems, Inc.2015-11-05
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A recall (Z-0204-2016)Philips Medical Systems, Inc.2015-11-03
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP sof recall (Z-1643-2015)Philips Medical Systems, Inc.2015-05-21
Philips Healthcare DigitalDiagnost System X-Ray recall (Z-1554-2015)Philips Medical Systems, Inc.2015-05-19
Philips Healthcare DuraDiagnost X- Ray recall (Z-1555-2015)Philips Medical Systems, Inc.2015-05-19
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS recall (Z-1307-2015)Philips Medical Systems, Inc.2015-03-20
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 71 recall (Z-1251-2015)Philips Medical Systems, Inc.2015-03-06
Philips Medical System Allura Xper X-Ray Angiographic recall (Z-1120-2015)Philips Medical Systems, Inc.2015-03-02
Philips Multi Diagnost Eleva II recall (Z-1044-2015)Philips Medical Systems, Inc.2015-02-26
Philips Multi Diagnost Eleva with FlatDetector recall (Z-1045-2015)Philips Medical Systems, Inc.2015-02-26
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a de recall (Z-0997-2015)Philips Medical Systems, Inc.2015-01-16
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M353 recall (Z-0963-2015)Philips Medical Systems, Inc.2015-01-13
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 9103 recall (Z-0206-2015)Philips Medical Systems, Inc.2014-12-16
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/ recall (Z-0236-2015)Philips Medical Systems, Inc.2014-12-16
Intended for both adult and pediatric patients for taking diagnostic radiographic exposure recall (Z-0508-2015)Philips Medical Systems, Inc.2014-12-16
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) an recall (Z-0203-2015)Philips Medical Systems, Inc.2014-12-12
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2. recall (Z-0181-2015)Philips Medical Systems, Inc.2014-11-07
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035 recall (Z-0182-2015)Philips Medical Systems, Inc.2014-11-07
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8 recall (Z-0104-2015)Philips Medical Systems, Inc.2014-10-21
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M recall (Z-0105-2015)Philips Medical Systems, Inc.2014-10-21
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system recall (Z-0022-2015)Philips Medical Systems, Inc.2014-10-09
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs recall (Z-2535-2014)Philips Medical Systems, Inc.2014-08-21
Ingenia 3.0T R5, magnetic resonance imaging system. recall (Z-1862-2014)Philips Medical Systems, Inc.2014-06-24
Ingenia 1.5T R5, magnetic resonance imaging system. recall (Z-1863-2014)Philips Medical Systems, Inc.2014-06-24
Ingenia 3.0T, magnetic resonance imaging system. recall (Z-1864-2014)Philips Medical Systems, Inc.2014-06-24
Ingenia 1.5T, magnetic resonance imaging system. recall (Z-1865-2014)Philips Medical Systems, Inc.2014-06-24
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Produc recall (Z-1826-2014)Philips Medical Systems, Inc.2014-06-18
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product recall (Z-1827-2014)Philips Medical Systems, Inc.2014-06-18
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Ce recall (Z-1746-2014)Philips Medical Systems, Inc.2014-06-10
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monito recall (Z-1628-2014)Philips Medical Systems, Inc.2014-05-16
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is recall (Z-1495-2014)Philips Medical Systems, Inc.2014-04-24
Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/6 recall (Z-1503-2014)Philips Medical Systems, Inc.2014-04-24
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00. recall (Z-1438-2014)Philips Medical Systems, Inc.2014-04-09
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defi recall (Z-1439-2014)Philips Medical Systems, Inc.2014-04-09
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Op recall (Z-1194-2014)Philips Medical Systems, Inc.2014-03-12
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4 recall (Z-1155-2014)Philips Medical Systems, Inc.2014-03-07
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended recall (Z-1107-2014)Philips Medical Systems, Inc.2014-02-26
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use fo recall (Z-1108-2014)Philips Medical Systems, Inc.2014-02-26
Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A recall (Z-1109-2014)Philips Medical Systems, Inc.2014-02-26
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M recall (Z-1110-2014)Philips Medical Systems, Inc.2014-02-26
Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M353 recall (Z-1118-2014)Philips Medical Systems, Inc.2014-02-26
HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStar recall (Z-1120-2014)Philips Medical Systems, Inc.2014-02-26
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, recall (Z-1090-2014)Philips Medical Systems, Inc.2014-02-25
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M353 recall (Z-0613-2014)Philips Medical Systems, Inc.2013-12-31
Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR i recall (Z-0584-2014)Philips Medical Systems, Inc.2013-12-27
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart recall (Z-0593-2014)Philips Medical Systems, Inc.2013-12-27
Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx recall (Z-0570-2014)Philips Medical Systems, Inc.2013-12-24
Easy Diagnost Eleva Universal Fluoroscopic applications recall (Z-0431-2014)Philips Medical Systems, Inc.2013-12-02
Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335. recall (Z-0563-03)Philips Medical Systems Inc2003-02-21

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