The Recall Desk

Manufacturer

Philips Medical Systems

16 recalls in our database name Philips Medical Systems as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
1
Most recent
2026-08-05

Of the 16 recalls from Philips Medical Systems we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) 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.

1–16 of 16

  • HighFDA (Devices)·Z-2651-2026·2026-08-05

    Philips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure

    Philips is recalling IQon Spectral CT systems because the clinical scan may not start automatically after Bolus Tracking, requiring manual triggering and potentially causing extra radiation exposure.

    Product
    IQon Spectral CT IQon Spectral CT Upgrades
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2650-2026·2026-08-05

    Philips CT Scanners Recalled Due to Bolus Tracking Trigger Issue

    Philips is recalling certain CT scanners because the clinical scan may not start automatically after Bolus Tracking, which could require a patient rescan and expose them to additional radiation.

    Product
    Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2026·2026-08-05

    Philips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue

    Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.

    Product
    Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2026·2026-04-22

    Philips Spectral CT on Rails recalled over three software issues

    Philips is recalling the Spectral CT on Rails after identifying three software issues affecting gantry movement, a confirmation prompt and head area planning. Three systems are affected.

    Product
    Philips Spectral CT on Rails. Model Number: 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2026·2025-11-05

    CT scanners recalled over six software faults affecting movement and dose

    Philips Medical Systems is recalling 105 Incisive CT scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0376-2026·2025-11-05

    CT 5300 scanners recalled over six software faults affecting movement and dose

    Philips Medical Systems is recalling 165 CT 5300 scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0377-2026·2025-11-05

    Brazil market CT scanner recalled over six software faults affecting movement

    Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1088-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images

    Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.

    Product
    CombiDiagnost R90 1.1 (709031)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Device May Display Wrong Patient Images

    The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.

    Product
    CombiDiagnost R90 1.0 (709030)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2024·2024-02-14

    Philips Spectral CT 7500 software issue causes incorrect image labeling

    Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.

    Product
    Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2024·2024-02-14

    Philips Spectral CT software issue causes image mislabeling

    A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.

    Product
    Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2017·2016-10-12

    Philips CT Scanner Recall for Infant Head Image Quality Defects

    Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product 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-0011-2017·2016-10-12

    Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects

    Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product 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-0012-2017·2016-10-12

    Philips Ingenuity CT Scanner Recalled for Infant Head Image Quality Issues

    Philips Medical Systems is recalling 235 Ingenuity CT scanners because infant head scans in High Resolution mode may produce degraded image quality, including non-uniformity and CT number shifts.

    Product
    Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product 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-0009-2017·2016-10-12

    Philips Brilliance 64 CT Scanner Recalled for Infant Head Image Quality Issues

    Philips Medical Systems is recalling 185 Brilliance 64 CT scanners because infant head scans in High Resolution mode may show degraded image quality.

    Product
    Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product 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-0745-2016·2016-02-10

    Philips Proton Therapy Planning Software Recalled for Dose Calculation Errors

    Philips Medical Systems is recalling DS/US Proton Feature software due to a defect that may cause incorrect dose calculations in radiation therapy planning.

    Product
    DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Philips Medical Systems

company based in Hamburg, Germany

Country
Germany
Founded
1987
Parent company
Philips (Germany)

Official website

Source: Wikidata (Q2087959), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.