The Recall Desk

Manufacturer

Philips Medical Systems (Cleveland), Inc.

315 recalls in our database name Philips Medical Systems (Cleveland), Inc. as the manufacturing or recalling firm.

What the numbers show

Total
315
Critical
0
Severe
26
Most recent
2025-09-24

Of the 315 recalls from Philips Medical Systems (Cleveland), Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

176–200 of 315

  • HighFDA (Devices)·Z-0177-2016·2015-11-04

    Philips Recalls Brilliance Big Bore CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 268 Brilliance Big Bore CT systems worldwide due to X-ray measurement errors causing image artifacts.

    Product
    Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2016·2015-11-04

    Philips Recalls Brilliance 64 CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.

    Product
    Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2016·2015-11-04

    Philips Ingenuity Core CT Systems Recalled for X-ray Measurement Error

    Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2016·2015-11-04

    Philips Ingenuity Core 128 CT Systems Recalled for X-ray Measurement Error

    Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2016·2015-11-04

    Philips Recalls Brilliance 16-Slice CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing Ring/Dot artifacts.

    Product
    Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0178-2016·2015-11-04

    Philips Recalls Ingenuity Flex CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2015·2015-09-09

    Philips Ingenuity TF PET/MR Systems Recalled for Potential Database Lockup

    Philips is recalling 11 Ingenuity TF PET/MR systems because the PET Reconstruction Server database may lock up between scans, though no field issues have been reported.

    Product
    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2259-2015·2015-08-05

    Philips Ingenuity CT Scanners Recalled for Software and Hardware Defects

    Philips is recalling 159 Ingenuity CT scanners due to software errors affecting dose control, image artifacts, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 82 Ingenuity Core CT systems due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2015·2015-08-05

    Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.

    Product
    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2015·2015-08-05

    Philips Brilliance iCT SP CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling two Brilliance iCT SP CT systems due to software issues affecting image quality, dose control, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 139 Ingenuity Core 128 CT scanners due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2254-2015·2015-08-05

    Philips Brilliance CT 64-Channel Systems Recalled for Software Defects

    Philips is recalling four Brilliance CT 64-channel systems due to software errors affecting image quality, dose control, and heart rate measurements.

    Product
    Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2194-2015·2015-07-29

    Philips Gemini LXL CT/PET Systems Recalled for Software Defects

    Philips is recalling two Gemini LXL CT/PET systems due to software defects that may cause incorrect radiation delivery to patients.

    Product
    GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2197-2015·2015-07-29

    Philips GEMINI TF Ready CT/PET System Software Defect Recall

    Philips is recalling GEMINI TF Ready CT/PET systems due to software defects that may cause incorrect radiation treatment.

    Product
    GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2195-2015·2015-07-29

    Philips Recalls GEMINI TF 16 Slice CT/PET Systems Due to Software Defects

    Philips is recalling 13 GEMINI TF 16 Slice CT/PET systems worldwide due to four software defects in the Tumor LOC application that may affect treatment accuracy.

    Product
    GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2196-2015·2015-07-29

    Philips GEMINI TF 64 Slice CT/PET System Software Defect Recall

    Philips is recalling 22 GEMINI TF 64 Slice CT/PET systems due to software defects that may cause incorrect tissue irradiation.

    Product
    GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2198-2015·2015-07-29

    Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects

    Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2015·2015-07-29

    Philips Recalls GEMINI TF Big Bore CT/PET Systems Due to Software Defects

    Philips is recalling 44 GEMINI TF Big Bore CT/PET systems worldwide because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2015·2015-07-29

    Philips Gemini GXL CT/PET System Software Recall for Tumor LOC Defects

    Philips is recalling two Gemini GXL 16 Slice CT/PET systems due to software defects in the Tumor LOC application that may cause incorrect tissue irradiation.

    Product
    GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2203-2015·2015-07-29

    Philips Recalls Head Holders for Ingenuity Core CT Systems

    Philips is recalling 79 head holders shipped with Ingenuity Core CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity Core 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.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2204-2015·2015-07-29

    Philips Recalls Head Holders for Ingenuity Core 128 CT Systems

    Philips Medical Systems is recalling 55 head holders shipped with Ingenuity Core 128 CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity Core 128 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.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2205-2015·2015-07-29

    Philips Recalls Head Holders Shipped with Ingenuity CT Systems

    Philips Medical Systems is recalling 66 head holders shipped with Ingenuity CT systems because they were not qualified for use on this specific model.

    Product
    Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-1783-2015·2015-06-17

    Philips TruFlight Select PET/CT Uninterruptible Power Supply Recall

    Philips is recalling 31 TruFlight Select PET/CT systems because the Uninterruptible Power Supply (UPS) accessory devices may leak battery acid, overheat, or emit fumes.

    Product
    TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1779-2015·2015-06-17

    Philips Precedence 6 UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling Precedence 6 UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide