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All Recalls

Every Philips Medical Systems (cleveland) Inc Recall

Sorted by most recent. Click any recall for full details.

201 recalls
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18...
Medical Devices·810 affected·Aug 5, 2025
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Medical Devices·169 affected·Aug 30, 2022
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Medical Devices·116 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Model # 728231, computed tomography x-ray system
Medical Devices·582 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
iCT, Model # 728306, computed tomography x-ray system
Medical Devices·128 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT, Model # 728326, computed tomography x-ray system
Medical Devices·92 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Medical Devices·12 affected·Jun 24, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT , Model Number 882482
Medical Devices·427 affected·Jun 10, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView SPECT, Model Number 882480
Medical Devices·696 affected·Jun 10, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView X , Model Number 882478
Medical Devices·117 affected·Jun 10, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT ...
Cardiac Devices·70 affected·Jun 3, 2019
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomogra...
Cardiac Devices·24 affected·Dec 19, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body b...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body ...
Medical Devices·6,343 affected·Oct 18, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imagin...
Cardiac Devices·61 affected·Sep 4, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by ...
Medical Devices·23 affected·Jul 3, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01...
Cardiac Devices·32 affected·May 21, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Medical Devices·2 affected·Mar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Medical Devices·20 affected·Mar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore Radiology 728244
Medical Devices·28 affected·Mar 28, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Ingenuity Core 728321
Medical Devices·28 affected·Mar 28, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core128 728323
Medical Devices·28 affected·Mar 28, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to prod...
Medical Devices·291 affected·Feb 21, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems...
Medical Devices·119 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produc...
Medical Devices·281 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems inten...
Medical Devices·2 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems inte...
Medical Devices·591 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to prod...
Medical Devices·151 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended t...
Medical Devices·172 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produ...
Medical Devices·6 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to pr...
Medical Devices·47 affected·Feb 8, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Medical Devices·63 affected·Jan 11, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear im...
Medical Devices·1,387 affected·Dec 15, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single p...
Medical Devices·1,387 affected·Dec 15, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission dat...
Medical Devices·3 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at differen...
Medical Devices·13 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data ta...
Medical Devices·1 affected·Nov 10, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Healthcare Brilliance iCT computed tomography x-ray system
Medical Devices·702 affected·Nov 8, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Medical Devices·134 affected·Nov 8, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Diagnostic Devices·2 affected·Nov 1, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Brilliance 64 computed tomography x-ray system
Medical Devices·1,801 affected·Oct 6, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Ingenuity Core computed tomography x-ray system
Medical Devices·0 affected·Oct 6, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to pro...
Medical Devices·64 affected·Jun 7, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-...
Medical Devices·1,890 affected·Jun 7, 2017