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.

151–175 of 315

  • ModerateFDA (Devices)·Z-1872-2016·2016-06-08

    Philips Brilliance 64 CT Systems Recalled for Software Mapping Error

    Philips Medical Systems is recalling 158 Brilliance 64 CT systems because the software may fail to map the Varian drive after a user logs out and back in.

    Product
    Brilliance 64 Computed Tomography X-ray Systems Product Usage: 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-1875-2016·2016-06-08

    Philips Ingenuity CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Computed Tomography X-ray Systems Product Usage: 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-1873-2016·2016-06-08

    Philips Ingenuity Core CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 300 Ingenuity Core CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Core Computed Tomography X-ray Systems, Product Usage: 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-1874-2016·2016-06-08

    Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

    Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

    Product
    Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: 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-1506-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling 33 units of AutoSPECT Pro software because it may incorrectly reconstruct cardiac SPECT data acquired at non-standard detector angles.

    Product
    IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1505-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling the AutoSPECT Pro software application because it may incorrectly reconstruct cardiac SPECT data acquired with non-standard detector angles.

    Product
    Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1504-2016·2016-04-27

    Philips AutoSPECT Pro Software Recalled for Incorrect Cardiac Image Reconstruction

    Philips Medical Systems is recalling the AutoSPECT Pro software application because it may produce erroneous results when processing cardiac SPECT data acquired at detector angles other than 90 or 180 degrees.

    Product
    Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1351-2016·2016-04-20

    Philips Brilliance 64 CT Systems Recalled for Software Data Transmission Error

    Philips Medical Systems is recalling 285 Brilliance 64 CT systems because a software error may prevent the automatic transmission of all image and data series to remote devices.

    Product
    Brilliance 64: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
    43 states
  • ModerateFDA (Devices)·Z-1356-2016·2016-04-20

    Philips Ingenuity CT Systems Recalled for Software Error in Data Transmission

    Philips Medical Systems is recalling 82 Ingenuity CT systems due to a software error that may prevent the automatic transmission of image data to remote devices.

    Product
    Ingenuity CT 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
    43 states
  • ModerateFDA (Devices)·Z-1354-2016·2016-04-20

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips is recalling 88 Ingenuity Core CT systems because a software error may prevent automatic transmission of image data to remote devices.

    Product
    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
    43 states
  • ModerateFDA (Devices)·Z-1353-2016·2016-04-20

    Philips Brilliance iCT SP CT Systems Recalled for Software Error

    Philips is recalling 49 Brilliance iCT SP CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT SP 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
    43 states
  • ModerateFDA (Devices)·Z-1355-2016·2016-04-20

    Philips Ingenuity Core 128 CT Systems Recalled for Software Error

    Philips is recalling 174 Ingenuity Core 128 CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    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
    43 states
  • ModerateFDA (Devices)·Z-1352-2016·2016-04-20

    Philips Brilliance iCT CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 324 Brilliance iCT Computed Tomography systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT 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
    43 states
  • HighFDA (Devices)·Z-1022-2016·2016-03-09

    Philips Recalls BrightView XCT Gamma Cameras Due to Mechanical Defects

    Philips is recalling 427 BrightView XCT gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.

    Product
    BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2016·2016-03-09

    Philips Recalls BrightView X Gamma Cameras Due to Motion and Collision Issues

    Philips Medical Systems is recalling 117 BrightView X gamma cameras worldwide due to potential gantry motion halts and collimator contact with the patient pallet.

    Product
    BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1020-2016·2016-03-09

    Philips Recalls BrightView Gamma Cameras Due to Motion and Collision Issues

    Philips Medical Systems is recalling 677 BrightView gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.

    Product
    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0548-2016·2015-12-30

    Philips CT System Recall for Missing Perfusion Scan Feature

    Philips is recalling 177 Ingenuity Core 128 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2016·2015-12-30

    Philips Ingenuity CT System Recall for Perfusion Software Access Issue

    Philips is recalling 31 Ingenuity CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2016·2015-12-30

    Philips Ingenuity Core CT System Recalled for Perfusion Software Access Issue

    Philips Medical Systems is recalling 135 Ingenuity Core CT systems because a software upgrade may have restricted access to the basic axial perfusion feature for some users.

    Product
    Ingenuity Core Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0545-2016·2015-12-30

    Philips Brilliance iCT CT System Recalled for Perfusion Software Issue

    Philips is recalling 51 Brilliance iCT CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0546-2016·2015-12-30

    Philips Brilliance iCT SP CT System Software Feature Recall

    Philips is recalling 12 Brilliance iCT SP CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT SP Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0544-2016·2015-12-30

    Philips Brilliance 64 CT System Recalled for Perfusion Software Issue

    Philips is recalling 30 Brilliance 64 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance 64 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2016·2015-12-16

    Philips Brilliance 64 CT System Recalled for Software Defects

    Philips is recalling 1,765 Brilliance 64 CT systems worldwide due to software defects that may cause operational errors, image issues, or misdiagnosis.

    Product
    Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2016·2015-12-16

    Philips Brilliance CT Scanner Software Recall for Incorrect Tumor Localization

    Philips is recalling Brilliance CT scanners with software version 2.0 because a printing error may display incorrect tumor locations, potentially leading to patient mistreatment.

    Product
    Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0197-2016·2015-11-11

    Philips Recalls GEMINI PET/CT Systems Due to Servo Controller Failure Risk

    Philips is recalling 264 GEMINI PET/CT systems because the CT subsystem's Spindle Block Servo Controllers may fail prematurely.

    Product
    GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    35 states