PlainRecalls

Philips Medical Systems (Cleveland) Inc

Compiled from official public sources by the publisher.

315 recalls on record · Latest: Sep 24, 2025

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Agency notice ledger

Federal filing book Philips Medical Systems HEAVY-BOOK · SINGLE-AGENCY

#34 of 14,151 · 315 notices · 0.302% archive

  • BOOK 315 notices
  • RANK #34 of 14,151
  • SHARE 0.302% archive
  • AGENCY FDA Devices (315)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 24, 2025
  • PHOTO Whole Foods Market

Nearest notice-volume peer: Whole Foods Market (3 notice gap)

Philips Medical Systems (Cleveland) Inc accounts for about 0.302% of the 104,423-notice archive on 315 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Philips Medical Systems compares to 14,151 recalling firms

Philips Medical Systems (Cleveland) Inc ranks 34th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Philips Medical Systems vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

315 34th of 14151 higher than 14,117 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Philips Medical Systems in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Philips Medical Systems (Cleveland) Inc holds about 0.302% of archive notices alongside 315 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Pinnacle TumorLOC 16.0.2 Model 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Pinnacle TumorLOC 14.0 Model 870200 UDI code: N/A Pinnacle3 Radiation Therapy Planning
FDA Devices Moderate Aug 13, 2025

Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
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 within the body for interpretation by medical personnel.
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 within the body for interpretation by medical personnel.
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 within the body for interpretation by medical personnel.
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 within the body for interpretation by medical personnel.
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 within the body for interpretation by medical personnel.
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 Aug 14, 2019

iCT SP Model # 728311, computed tomography x-ray system
FDA Devices Moderate Aug 14, 2019

Ingenuity Core Model # 728321, computed tomography x-ray system
FDA Devices Moderate Aug 14, 2019

Vereos PET/CT Model # 882446, computed tomography x-ray system
FDA Devices Moderate Aug 14, 2019

IQon Spectral CT Model # 728332, 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 images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various dis
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 reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Devices Moderate Apr 24, 2019

Brilliance iCT, 728306 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Devices Moderate Apr 24, 2019

Brilliance 64, 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
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) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imagin
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 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 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 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 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 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 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 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 Devices Moderate Dec 12, 2018

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 Devices Moderate Dec 12, 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 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-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 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 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 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 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 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 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. Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by compute
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 that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecti
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-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 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 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 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-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 Devices Moderate Nov 7, 2018

Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 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 Devices Moderate Nov 7, 2018

Brilliance iCT (Model No. 728306), Software Version 4.1.6 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 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)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)00884838059559(21)900015 (01)00884838059559(21)900016 (01)00884838059559(21)900017 (01)00
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 Jul 4, 2018

Ingenuity TF PET/CT 882442
FDA Devices Moderate Jul 4, 2018

Ingenuity Core128/Elite China 728324
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 Jun 20, 2018

Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system

Philips Medical Systems carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Beckman Coulter, Inc. 332 Windstone Medical Packaging, Inc. 336 Smiths Medical Asd, Inc. 293 Covidien LLC 340

Frequently Asked Questions

How many federal recall notices name Philips Medical Systems? ▼
PlainRecalls indexes 315 distinct federal recall events naming Philips Medical Systems (Cleveland) Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Philips Medical Systems sit among other recalling firms? ▼
Philips Medical Systems (Cleveland) Inc ranks #34 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Philips Medical Systems's notices? ▼
FDA Devices accounts for 315 of this firm's 315 indexed notices.
What product category dominates Philips Medical Systems's filing book? ▼
Filings for Philips Medical Systems (Cleveland) Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Philips Medical Systems (Cleveland) Inc: 315 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Philips Medical Systems (Cleveland) Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026