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 0 critical, 49 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 50 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 Jan 18, 2017 to Apr 25, 2018.

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 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 Apr 25, 2018

Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sec…

FDA Devices Moderate Apr 25, 2018

Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produc…

FDA Devices Moderate Apr 25, 2018

Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission …

FDA Devices Moderate Apr 25, 2018

Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-…

FDA Devices Moderate Apr 25, 2018

Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to …

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 Mar 14, 2018

Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produc…

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 Feb 14, 2018

BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates…

FDA Devices Moderate Feb 14, 2018

BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging ac…

FDA Devices Moderate Feb 14, 2018

Philips Ingenuity CT computed tomography x-ray system

FDA Devices Moderate Feb 14, 2018

Philips Ingenuity Core 128 computed tomography x-ray system

FDA Devices Moderate Feb 14, 2018

Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nucle…

FDA Devices Moderate Jan 31, 2018

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

FDA Devices Moderate Jan 31, 2018

Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems

FDA Devices Moderate Jan 24, 2018

Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at d…

FDA Devices Moderate Jan 24, 2018

Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and…

FDA Devices Moderate Jan 24, 2018

Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at diffe…

FDA Devices Moderate Jan 24, 2018

Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at differ…

FDA Devices Moderate Jan 17, 2018

Philips Healthcare Brilliance iCT computed tomography x-ray system

FDA Devices Moderate Jan 17, 2018

Philips Healthcare Brilliance iCT SP computed tomography x-ray system

FDA Devices Moderate Jan 17, 2018

Philips Healthcare IQon Spectral CT computed tomography x-ray system

FDA Devices Moderate Apr 12, 2017

BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating …

FDA Devices Moderate Apr 12, 2017

BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodatin…

FDA Devices Low Apr 12, 2017

BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodatin…

FDA Devices Moderate Apr 12, 2017

BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodatin…

FDA Devices Moderate Mar 29, 2017

Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconst…

FDA Devices Moderate Mar 29, 2017

Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recons…

FDA Devices Moderate Mar 22, 2017

882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform p…

FDA Devices Moderate Mar 22, 2017

882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies.…

FDA Devices Moderate Mar 22, 2017

882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform…

FDA Devices Moderate Feb 22, 2017

BrightView X upgraded to XCT 882454

FDA Devices Moderate Feb 22, 2017

BrightView XCT

FDA Devices Moderate Feb 1, 2017

Brilliance iCT

FDA Devices Moderate Jan 18, 2017

Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstructio…

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.