1,733 results
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Sources: EU EUDAMED, US FDA
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Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·August 13, 2025
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·August 13, 2025
DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. The device is manufactured by Philips Medical Systems DMC GmbH, RontgenstraBe 24, 22335 Hamburg, Germany.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code KPR·December 13, 2007
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 30, 2018
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 30, 2018
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·August 13, 2025
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
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
FDA Recall
Terminated
·Neusoft Medical Systems Co., Ltd. NO.·Product code JAK·May 2, 2015
Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 18, 2018
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·August 13, 2025
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·August 13, 2025
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·August 13, 2025
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 18, 2018
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·August 13, 2025
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 18, 2018
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 18, 2018
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 18, 2018
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 18, 2018
Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code MOS·September 30, 2008
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