FDA Device Recalls

Recalls / Firms / Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips

131 FDA device recalls on record.

DateClassProductReason
2012-07-26Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and
2012-07-26Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Syste
2011-06-01The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system.
2011-04-01PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911. D
2010-12-14Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluorosc
2010-12-14Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and F
2010-12-14Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopi
2010-11-04Allura XPER FD 20 and and Allura CV20; Allura XPER FD 10 and Field Extension for XPER Cardiovascula
2010-11-04Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allu
2010-10-07Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluorosco
2010-10-07Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185.
2010-10-07Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, ang
2010-10-07Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184.
2010-09-09The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the b
2010-09-09The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold th
2010-02-05The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shi
2010-02-04MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/A
2010-02-04BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and I
2010-01-21BuckyDiagnost. General Radiography and Tomography examination of patients in supine, seated, or stan
2010-01-21DigitalDiagnost. General radiographic examinations and applications wherever a solid state X-ray ima
2010-01-21EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angio
2009-07-06EasyDiagnost
2009-07-06Diagnost 76
2009-07-06LithoDiagnost
2009-07-06UroDiagnost
2009-07-06Diagnost 96/97 DSI
2009-07-06OmniDiagnost
2009-07-06Easy Diagnost Digital
2009-07-06MultiDiagnost MD4
2009-07-06MultiDiagnost MD3
2009-05-26ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this report are
2009-05-26MultiDiagnost Eleva with FD. The Philips MultiDiagnost Eleva intended use is for the following appl
2009-05-26Allura XPER X-ray system. The intended uses of the Allura XPER X-ray systems involved with this repo
2009-05-26Allura XPER FD10 F/C The intended uses of the Allura XPER X-ray systems involved with this report ar
2009-05-26ALLURA XPER FD20/10 The intended uses of the Allura XPER X-ray systems involved with this report are
2009-05-26ALLURA XPER FD20 The intended uses of the Allura XPER X-ray systems involved with this report are an
2009-05-12Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of di
2009-05-01The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.
2009-03-06Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips EasyDiagnost Eleva int
2009-03-06Philips MultiDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips MultiDiagnost Eleva i
2009-03-06Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips OmniDiagnost Eleva is
2009-01-30Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is int
2009-01-21Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F syste
2008-12-30Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or high
2008-12-23PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Ph
2008-12-10EasyDiagnost Eleva x-ray systems
2008-12-10Integris Allura Flat Detector 9C
2008-12-10Allura XPER 10/10
2008-12-10OminDiagnost Eleva
2008-12-10MultiDiagnost Eleva
2008-12-10Integris XPER FD10 F/C
2008-12-10Integris H5000F
2008-12-10Integris BH5000
2008-12-10Allura XPER FD20
2008-12-10Allura XPER FD20/10
2008-11-21The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Syste
2008-10-23Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara Generator can be
2008-10-23Philips Integris BH5000 Angiographic X-ray system. This system with Velara Generator can be identif
2008-10-23Philips Allura XPER FD20 Angiographic X-ray system. This system with Velara Generator can be identi
2008-10-23Philips Integris H5000F Angiographic X-ray system. This system with Velara Generator can be identif
2008-10-23Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be ident
2008-10-23Philips Integris Allura Flat Detector 9C Angiographic X-ray system. This system with Velara Generat
2008-10-23Philips Allura XPER FD 20/10 Angiographic X-ray system. This system with Velara Generator can be id
2008-09-30Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil
2008-09-19Vista Nuclear Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 M
2008-09-19Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. Wor
2008-09-19Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging Sys
2008-09-19Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker International, Inc. Wo
2008-09-19Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system,
2008-09-19Infinion is Nuclear Magnetic Resonance Imaging. Philips Infinion 1.5T System, Picker International,
2008-09-10Philips BV Endura Mobile X-Ray system with the extended rotation option.
2008-09-10Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
2008-09-05Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X
2008-09-05Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-r
2008-08-21Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imagi
2008-08-21Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imag
2008-08-15Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams,
2008-07-09The Philips EasyDiagnost Eleva with DRF. Philips Medical Systems multifunctional x-ray system.
2008-06-26Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray system
2008-05-23General X-Ray System types with Digital Spot Imaging (DSI) software
2008-04-10NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray comput
2008-04-08Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The dev
2008-03-22Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fl
2008-03-14AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting b
2008-03-10EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V
2008-02-07Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615.
2008-01-04Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for t
2008-01-04EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film option and i
2008-01-04Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create dig
2007-12-13DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Dete
2007-11-29MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Syst
2007-09-24Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
2007-09-24Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021
2007-08-23Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
2007-08-23Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)
2007-07-23Philips Multi Diagnost Eleva
2007-07-23Philips Easy Diagnost X-Ray System
2007-07-23Philips Omni Diagnost Eleva
2007-07-23Philips Easy Diagnost Eleva
2007-07-23Philips Bucky DIagnost X-Ray System
2007-07-23Philips Digital Diagnost X-Ray system
2007-04-30Panorama 1.0T MRI
2007-04-30Gyroscan MRI
2007-04-30Intera MRI
2007-04-30Achieva MRI
2007-03-23Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and ar
2007-03-23Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and a
2007-03-23Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and a
2007-03-15Philips Collimators, Model numbers: 9896 010 00614, 9896 010 00615, 9804 607 00301, and 9804 602 835
2006-12-14Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling models). A mo
2006-12-14FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector
2006-12-14FD 20/10 X-Ray System, Angiograph, biplane, digital Allura FD, 10' and 20' detectors
2006-12-14Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a
2006-12-14Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifi
2006-12-14Allura FD20 x-ray system, angiograph, monoplane, digital Allura FD with a 20' detector FD
2006-10-12Allura X-per FD 10/10 x-ray, and fluoroscopy
2006-10-12Allura Xper FD 20/10 x-ray, and fluoroscopy
2006-08-24Allura Xper FD 10 x-ray, angiographic system
2006-08-24Allura Xper FD 10/10 x-ray, angiographic system
2006-07-01Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Plan
2006-04-06MD4 X-ray system
2006-04-06MD3 X-ray system
2006-02-06Allura Xper FD10 x-ray system
2006-02-06Allura Xper FD10/10 x-ray system
2005-12-09Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
2005-10-12AD6 table, modified, used with the XPER systems. The modification on the table is the cables used
2005-10-12AD5 table for use with Integris and Integris Allura x-ray systems
2005-10-12AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables
2005-10-12AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
2005-07-27Interis Allura BiPlane X-Ray System
2005-04-29View Forum 2003 software, SW 3.4L1