PlainRecalls

Philips Medical Systems (Cleveland) Inc

Compiled from official public sources by the editorial team.

315 recalls on record · Latest: Sep 24, 2025

Philips Medical Systems (Cleveland) Inc Recall Insight

Philips Medical Systems (Cleveland) Inc appears on 315 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.310% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Sep 24, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 5 critical, 45 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 49 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jun 20, 2018 to Sep 24, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 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 wi…

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 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 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 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 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 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 Apr 24, 2019

Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer recons…

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 reconst…

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 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 b…

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 b…

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 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 cr…

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 Im…

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 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

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Philips Medical Systems (Cleveland) Inc with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.