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.

301–315 of 315

  • HighFDA (Devices)·Z-0674-2013·2013-01-23

    Philips Recalls Brilliance 64 and Ingenuity CT Scanners Due to Software Anomalies

    Philips Medical Systems is recalling nine CT scanning systems due to software anomalies that could pose a risk of injury to patients and personnel if the issues recur.

    Product
    Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to pr
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0675-2013·2013-01-23

    Philips CT System Software Recall for Coronary Artery Labeling Defect

    Philips is recalling 108 CT systems because a software defect prevents users from labeling coronary arteries in rendered images.

    Product
    Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by c
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0479-2013·2013-01-02

    Philips CT System Software Update Addresses Nonhazardous Reliability Issues

    Philips is updating Extended Brilliance Workspace software to version 4.5.5 to fix nonhazardous reliability issues and improve system functionality.

    Product
    Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0206-2013·2012-11-14

    Philips Recalls Pinnacle3 Virtual Client Connection Software Due to Improper Release

    Philips Medical Systems is recalling 11 units of Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and distribution.

    Product
    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or mali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2012·2012-10-03

    Philips CT Systems Recalled Due to Potential Oil Accumulator Bolt Failure

    Philips is recalling 112 Computed Tomography X-Ray Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.

    Product
    Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images o
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2386-2012·2012-09-26

    Philips Recalls MX 16-slice CT Scanners Due to Bolt Failure Risk

    Philips Medical Systems is recalling 328 MX 16-slice CT Scanner Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.

    Product
    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2404-2012·2012-09-26

    Philips Brilliance CT 16 System Recalled for Software Logout Failure

    Philips is recalling 93 Brilliance CT 16 systems because a software defect may cause the system to fail to log out, requiring a forced restart.

    Product
    The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2223-2012·2012-08-29

    Philips CT Scanner Recall for Dose Limit Software Defect

    Philips is recalling eight Brilliance 64 and Ingenuity CT scanners because a software update allows users to disable dose alerts, potentially permitting scans that exceed safety limits.

    Product
    The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and displ
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2239-2012·2012-08-29

    Philips PET/CT Systems Recalled Due to UPS Battery Thermal Runaway

    Philips is recalling seven PET/CT systems because a UPS battery cabinet experienced thermal runaway, causing a battery to overheat and burn through the casing.

    Product
    Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2012·2012-08-29

    Philips CT Systems Recalled for Potential Patient Support Movement

    Philips is recalling 126 CT systems because a damaged foot switch cover may cause the patient support to move unexpectedly.

    Product
    The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2012·2012-07-25

    Philips Brilliance CT Scanners Recalled for Defective Carbon Table Top Bolts

    Philips Medical Systems is recalling 524 Brilliance CT scanners because defective bolts securing the carbon table top may break off.

    Product
    Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at differen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2012·2012-07-18

    Philips Intellispace Portal software recalled for tumor measurement errors

    Philips Medical Systems is recalling Intellispace Portal software because tumor measurements are not recalculated when lesion contours are edited.

    Product
    Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1988-2012·2012-07-18

    Philips Recalls Intellispace Portal Software Due to Missing Warning Messages

    Philips is recalling 96 Intellispace Portal software units to fix a defect where the system fails to display a warning message when launching multiple patient studies.

    Product
    Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2012·2012-07-18

    Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software

    Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.

    Product
    IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2012·2012-06-20

    Philips Brilliance iCT and iCT SP CT Systems Software Update Recall

    Philips is issuing a software update for Brilliance iCT and iCT SP systems to address non-conformances that do not result in unacceptable hazards.

    Product
    The Brilliance iCT and iCT SP are 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. These devices may include signal analysis and display equipment,
    Category
    Medical Device
    Distribution
    22 states