Philips Medical Systems (Cleveland) Inc
215 recalls on record · Latest: Sep 24, 2025
FDA Devices Moderate Sep 24, 2025
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 …
FDA Devices Moderate Sep 21, 2022
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
FDA Devices Critical Nov 13, 2019
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes wi…
FDA Devices Moderate Aug 14, 2019
Ingenuity Core128 Model # 728323, computed tomography x-ray system
FDA Devices Moderate Aug 14, 2019
Brilliance 64 Model # 728231, computed tomography x-ray system
FDA Devices Moderate Aug 14, 2019
iCT, Model # 728306, computed tomography x-ray system
FDA Devices Moderate Aug 14, 2019
Ingenuity CT, Model # 728326, computed tomography x-ray system
FDA Devices Moderate Aug 14, 2019
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
FDA Devices Moderate Jul 31, 2019
BrightView XCT , Model Number 882482
FDA Devices Moderate Jul 31, 2019
BrightView SPECT, Model Number 882480
FDA Devices Moderate Jul 31, 2019
BrightView X , Model Number 882478
FDA Devices Moderate Jul 10, 2019
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem im…
FDA Devices Moderate Apr 24, 2019
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer rec…
FDA Devices Moderate Feb 20, 2019
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) an…
FDA Devices Moderate Dec 12, 2018
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by…
FDA Devices Moderate Dec 12, 2018
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer r…
FDA Devices Moderate Dec 12, 2018
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body…
FDA Devices Moderate Dec 12, 2018
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer …
FDA Devices Moderate Nov 7, 2018
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-s…
FDA Devices Moderate Nov 7, 2018
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Im…
FDA Devices Moderate Nov 7, 2018
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce c…
FDA Devices Moderate Nov 7, 2018
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Imag…
FDA Devices Moderate Nov 7, 2018
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device tha…
FDA Devices Moderate Nov 7, 2018
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectiona…
FDA Devices Moderate Nov 7, 2018
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Ima…
FDA Devices Moderate Nov 7, 2018
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sec…
FDA Devices Moderate Jul 25, 2018
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059…
FDA Devices Moderate Jul 4, 2018
Brilliance Big Bore Radiology 728244
FDA Devices Moderate Jul 4, 2018
Philips Ingenuity Core 728321
FDA Devices Moderate Jul 4, 2018
Ingenuity Core128 728323
FDA Devices Moderate Jun 20, 2018
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
FDA Devices Moderate Jun 20, 2018
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
FDA Devices Moderate Apr 25, 2018
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to…
FDA Devices Moderate Apr 25, 2018
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-se…
FDA Devices Moderate Apr 25, 2018
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sect…
FDA Devices Moderate Apr 25, 2018
Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produ…
FDA Devices Moderate Apr 25, 2018
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to prod…
FDA Devices Moderate Apr 25, 2018
Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-se…
FDA Devices Moderate Apr 25, 2018
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cr…
FDA Devices Moderate Apr 25, 2018
Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sec…
FDA Devices Moderate Apr 25, 2018
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-…
FDA Devices Moderate Mar 14, 2018
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
FDA Devices Moderate Mar 14, 2018
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce…
FDA Devices Moderate Feb 21, 2018
Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tom…
FDA Devices Moderate Feb 14, 2018
Philips Brilliance 64 computed tomography x-ray system
FDA Devices Moderate Feb 14, 2018
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
FDA Devices Moderate Feb 14, 2018
Philips Ingenuity Core computed tomography x-ray system
FDA Devices Moderate Feb 14, 2018
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accomm…
FDA Devices Moderate Feb 14, 2018
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclea…
FDA Devices Moderate Jan 31, 2018