Philips Medical Systems (Cleveland) Inc

Complete recall history across all FDA and CPSC categories — 313 total recalls

Philips Medical Systems (Cleveland) Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (313)

FDA medical device enforcement actions by Philips Medical Systems (Cleveland) Inc. Showing most recent 50.

Date Product Reason Class
Aug 5, 2025 Pinnacle Radiation Therapy Planning System: Multimodality Simulation Works... Due to a software issue, there is a potential image error of the Region of In... Class II
Jul 17, 2025 Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software Due to software issue, Radiation Therapy Planning system may provide incorre... Class II
Aug 30, 2022 Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. When computing a radiation dose in the system, the exported dose information ... Class II
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in eith... Class I
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in eith... Class I
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in eith... Class I
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in eith... Class I
Sep 19, 2019 Forte Gamma Camera System is intended to produce images depicting the anatomi... An issue with the Detector for the Forte Family of cameras may result in eith... Class I
Jun 24, 2019 IQon Spectral CT Model # 728332, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 Vereos PET/CT Model # 882446, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 Ingenuity Core Model # 728321, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 iCT SP Model # 728311, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 Ingenuity CT, Model # 728326, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 iCT, Model # 728306, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 Brilliance 64 Model # 728231, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 24, 2019 Ingenuity Core128 Model # 728323, computed tomography x-ray system In certain instances when performing a cardiac step and shoot acquisition wit... Class II
Jun 10, 2019 BrightView X , Model Number 882478 An issue with the handcontroller may result in either spontaneous uncommanded... Class II
Jun 10, 2019 BrightView SPECT, Model Number 882480 An issue with the handcontroller may result in either spontaneous uncommanded... Class II
Jun 10, 2019 BrightView XCT , Model Number 882482 An issue with the handcontroller may result in either spontaneous uncommanded... Class II
Jun 3, 2019 Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomograp... The Vereos PET/CT may have misaligned front and rear covers, which may result... Class II
Dec 19, 2018 Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagn... A software update is being issued to correct multiple issues identified in th... Class II
Oct 18, 2018 Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the g... Class II
Oct 18, 2018 Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomograph... There is a potential for separation of fiberglass resin which may cause the g... Class II
Oct 18, 2018 Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray sys... There is a potential for separation of fiberglass resin which may cause the g... Class II
Oct 18, 2018 Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomogra... There is a potential for separation of fiberglass resin which may cause the g... Class II
Oct 18, 2018 Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray syst... There is a potential for separation of fiberglass resin which may cause the g... Class II
Oct 18, 2018 Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography... There is a potential for separation of fiberglass resin which may cause the g... Class II
Sep 4, 2018 Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usa... Software Correction: Software errors that may result in incorrect 4D CT image... Class II
Jul 3, 2018 Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems in... Philips has identified that the compensator within the X-ray tube collimator ... Class II
Jul 3, 2018 Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems i... Philips has identified that the compensator within the X-ray tube collimator ... Class II
Jul 3, 2018 Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray system... Philips has identified that the compensator within the X-ray tube collimator ... Class II
May 21, 2018 Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01... The block used to connect the patient pallet to the couch may be assembled in... Class II
Mar 30, 2018 Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 7282... The patient support head holder could contact the back ISO shelter wall durin... Class II
Mar 30, 2018 Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 72... The patient support head holder could contact the back ISO shelter wall durin... Class II
Mar 30, 2018 Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 7282... The patient support head holder could contact the back ISO shelter wall durin... Class II
Mar 28, 2018 Ingenuity Core128/Elite China 728324 A problem has been detected in the X-Ray Tube. The affected tubes have a prod... Class II
Mar 28, 2018 Ingenuity TF PET/CT 882442 A problem has been detected in the X-Ray Tube. The affected tubes have a prod... Class II
Mar 28, 2018 Ingenuity Core128 728323 A problem has been detected in the X-Ray Tube. The affected tubes have a prod... Class II
Mar 28, 2018 Philips Ingenuity Core 728321 A problem has been detected in the X-Ray Tube. The affected tubes have a prod... Class II
Mar 28, 2018 Brilliance Big Bore Radiology 728244 A problem has been detected in the X-Ray Tube. The affected tubes have a prod... Class II
Feb 21, 2018 Brilliance 64 with 4.1.7 XX026 software version model number 728231 Produc... Surview scan with tube current lower than 30 mA is unable to be initialized. Class II
Feb 15, 2018 Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an int... Following a period of inactivity, the mass storage device may cause the acqui... Class II
Feb 8, 2018 Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray ... Closing the Emergency Stop may disable the horizontal motor, allowing the cou... Class II
Feb 8, 2018 Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Prod... Closing the Emergency Stop may disable the horizontal motor, allowing the cou... Class II
Feb 8, 2018 Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system... Closing the Emergency Stop may disable the horizontal motor, allowing the cou... Class II
Feb 8, 2018 Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product... Closing the Emergency Stop may disable the horizontal motor, allowing the cou... Class II
Feb 8, 2018 IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Prod... Closing the Emergency Stop may disable the horizontal motor, allowing the cou... Class II
Feb 8, 2018 Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product... Closing the Emergency Stop may disable the horizontal motor, allowing the cou... Class II
Feb 8, 2018 Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system ... Closing the Emergency Stop may disable the horizontal motor, allowing the cou... Class II

View all 313 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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