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.

76–100 of 315

  • ModerateFDA (Devices)·Z-0520-2018·2018-02-14

    Philips CT System Recalled for Software Issues

    Philips Medical Systems is recalling Ingenuity Core 128 CT systems due to software issues in version 4.1.6.

    Product
    Philips Ingenuity Core 128 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0519-2018·2018-02-14

    Philips Ingenuity Core CT System Software Recall

    Philips Medical Systems is recalling Ingenuity Core CT systems due to software issues in Brilliance iCT 4.1.6.

    Product
    Philips Ingenuity Core computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0521-2018·2018-02-14

    Philips Ingenuity CT System Recalled for Software Issues

    Philips Medical Systems is recalling Ingenuity CT systems due to software issues in version 4.1.6. The recall affects 26 US government accounts.

    Product
    Philips Ingenuity CT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0402-2018·2018-01-31

    Philips Brilliance iCT CT Systems Recalled for Software Defects

    Philips is recalling Brilliance iCT CT systems due to software issues affecting scan functions and safety features.

    Product
    Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2018·2018-01-31

    Philips Brilliance iCT CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling 559 Brilliance iCT CT systems due to software issues affecting scan functions and safety features.

    Product
    Brilliance iCT - Model 728306 Computed Tomography X-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2018·2018-01-24

    Philips Ingenuity Core CT Scanner Recall for Fastener Torque Verification

    Philips is recalling one Ingenuity Core CT scanner because certain fasteners cannot be confirmed to be torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0391-2018·2018-01-24

    Philips Ingenuity Core 128 CT Scanner Recall for Fastener Torque Issues

    Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0389-2018·2018-01-24

    Philips Brilliance 64 CT Scanner Recalled for Fastener Torque Issues

    Philips is recalling one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.

    Product
    Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0388-2018·2018-01-24

    Philips Brilliance iCT Recalled for Potential Fastener Torque Defect

    Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0333-2018·2018-01-17

    Philips IQon Spectral CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling IQon Spectral CT systems because screws holding the internal gantry to the main bearing may come loose, potentially causing noise.

    Product
    Philips Healthcare IQon Spectral CT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0331-2018·2018-01-17

    Philips Brilliance iCT CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling 702 Brilliance iCT computed tomography systems because screws holding an internal gantry component may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0332-2018·2018-01-17

    Philips Brilliance iCT SP CT Scanner Recall Due to Loose Screws

    Philips is recalling 134 Brilliance iCT SP CT scanners because screws holding the internal gantry may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT SP computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1751-2017·2017-04-12

    Philips BrightView XCT Gamma Cameras Recalled for Brake Hub Assembly Error

    Philips is recalling 90 BrightView XCT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1752-2017·2017-04-12

    Philips BrightView X Gamma Camera Recall for Brake Hub Assembly Error

    Philips is recalling BrightView X 3/4 gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, an
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1750-2017·2017-04-12

    Philips Recalls 84 BrightView SPECT Gamma Cameras Due to Brake Hub Defect

    Philips is recalling 84 BrightView SPECT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, an
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1753-2017·2017-04-12

    Philips BrightView X Gamma Camera Recall Due to Brake Hub Assembly Error

    Philips Medical Systems is recalling 27 BrightView X gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, an
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1493-2017·2017-03-29

    Philips Recalls Brilliance BigBore CT Scanners Due to Image Reconstruction Error

    Philips is recalling 67 Brilliance BigBore CT scanners because 4D CT images may be reconstructed at a single phase while incorrectly labeled as specific phases.

    Product
    Brilliance BigBore Radiology CT - 728244 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 analysts and display equ
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1492-2017·2017-03-29

    Philips CT Scanner Recall for Incorrect 4D CT Image Phase Annotations

    Philips is recalling 11 Brilliance BigBore Oncology CT scanners because retrospective 4D CT scans may display incorrect phase annotations.

    Product
    Brilliance BigBore Oncology CT - 728243 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 analysts and display equi
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1479-2017·2017-03-22

    Philips BrightView XCT Nuclear Imaging Systems Recalled for Four Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView XCT nuclear imaging systems worldwide due to four hardware issues, including motion controller failures and door interlock problems.

    Product
    882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2017·2017-03-22

    Philips BrightView X Nuclear Imaging System Recalled for Four Software and Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView X nuclear imaging systems worldwide due to four issues: motion controller failures, door interlock problems, detector contact risks, and software freezes.

    Product
    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 planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1480-2017·2017-03-22

    Philips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues

    Philips Medical Systems is recalling 1,218 BrightView nuclear imaging systems worldwide due to four issues, including motion controller failures and software freezes.

    Product
    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2017·2017-01-18

    Philips IQon Spectral CT Recalled for Image and Scan Errors

    Philips is recalling 35 IQon Spectral CT systems due to software issues causing rescans, incorrect scan locations, or misrepresentation of image results.

    Product
    IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This devic
    Category
    Medical Device
    Distribution
    Distributed nationwide