145 results
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100ms
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Sources: EU EUDAMED, US FDA
Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZI·August 21, 2008
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·April 10, 2008
Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZI·August 21, 2008
SYNERGY BODY COIL
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code MOS·June 2, 2010
URO DIAGNOST MRF
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code IZO·September 29, 2004
PHILIPS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code JAA·September 1, 1998
PHILLIPS
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code IXL·September 10, 1998
PHILIPS MEDICAL
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code IXR·February 13, 1998
DIAGNOST EPC
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code KXJ·February 6, 1998
POLY DIAGNOST UV
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code IZI·December 17, 1997
MD4 MULTIPURPOSE FLUORO ROOM
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code JAA·December 23, 1998
MULTI DIAGNOST 4 FOOT REST
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.·Product code IZO·October 2, 2002
Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options enable mammography reading, teleradiology, fast demonstration, 3D, etc. Device accessories enable orthopedic pre-operative planning; angiography/cardiology imaging capabilities; and bone densitometry capabilities. Typical users are trained professionals such as physicians, radiologists, nurses, medical technicians and assistants.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code LLZ·January 30, 2009
Philips Medical Systems Nederland B.V.
Authorized representative
🇳🇱 Netherlands·21 Manufacturers·1029 Devices
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·June 8, 2012
PHILIPS
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEM NORTH AMERICA CO·Product code KXJ·December 29, 2000
Allura Xper FD10/10 x-ray system
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZI·February 6, 2006
FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZI·December 14, 2006