Philips Medical Systems (Cleveland) Inc
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.
Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 …
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes wi…
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes wi…
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes wi…
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes wi…
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes wi…
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Brilliance 64 Model # 728231, computed tomography x-ray system
iCT, Model # 728306, computed tomography x-ray system
Ingenuity CT, Model # 728326, computed tomography x-ray system
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
iCT SP Model # 728311, computed tomography x-ray system
Ingenuity Core Model # 728321, computed tomography x-ray system
Vereos PET/CT Model # 882446, computed tomography x-ray system
IQon Spectral CT Model # 728332, computed tomography x-ray system
BrightView XCT , Model Number 882482
BrightView SPECT, Model Number 882480
BrightView X , Model Number 882478
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem im…
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer rec…
Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer recons…
Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconst…
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) an…
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by…
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer r…
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body…
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer …
Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body b…
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body b…
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…
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Im…
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce c…
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Imag…
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…
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectiona…
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Ima…
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…
Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cr…
Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Im…
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059…
Brilliance Big Bore Radiology 728244
Philips Ingenuity Core 728321
Ingenuity Core128 728323
Ingenuity TF PET/CT 882442
Ingenuity Core128/Elite China 728324
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
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.
Zimmer Biomet, Inc.
View recalls →
MEDLINE INDUSTRIES, LP - Northfield
View recalls →
Siemens Medical Solutions USA, Inc
View recalls →
FORD
View recalls →
Customed, Inc
View recalls →
Compare Philips Medical Systems (Cleveland) Inc with Zimmer Biomet, Inc. →
Data Sources
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.