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.

276–300 of 315

  • HighFDA (Devices)·Z-0785-2014·2014-01-29

    Philips Recalls ADAC Gamma Camera Systems Due to Fork Joint Crack Risk

    Philips Medical Systems is recalling ADAC ARGUS and CIRRUS Gamma Camera Systems because routine maintenance may fail to detect small cracks in the fork weldments.

    Product
    ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0801-2014·2014-01-29

    Philips CT Scanner Recall for Obscured Machine Name Label

    Philips is recalling 32 CT scanners because the machine name label is obscured in TumorLOC Basic Mode, preventing users from viewing or changing the name.

    Product
    Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2014·2013-11-27

    Philips Brilliance iCT CT Scanner Recall for Footrest Contact Hazard

    Philips is recalling nine Brilliance iCT CT scanners because the footrest extension can contact the gantry or user during operation.

    Product
    Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2014·2013-11-06

    Philips Ingenuity TF PET/CT Software Recall for Potential Radiopharmaceutical Re-injection Risk

    Philips is recalling 13 Ingenuity TF PET/CT systems due to software issues that could require patients to be re-injected with PET radiopharmaceuticals during rescans.

    Product
    Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0089-2014·2013-11-06

    Philips Recalls BrightView XCT Gamma Cameras Due to Latch Failure

    Philips is recalling 371 BrightView XCT gamma cameras because the Flat Panel Detector may not remain securely latched in the stowed position.

    Product
    BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging com
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-0033-2014·2013-10-30

    Philips MRI Systems Recalled for Potential Water Freezing in Venting System

    Philips Medical Systems is recalling 511 MRI systems because water may collect and freeze in the vent pipe, potentially blocking the magnet venting system.

    Product
    Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2014·2013-10-23

    Philips MX 16-Slice CT Scanner Recalled for Pinch Point Injury Risk

    Philips Medical Systems is recalling 326 MX 16-Slice CT Scanner Systems because a pinch point at the end of the table top can cause injury.

    Product
    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0013-2014·2013-10-23

    Philips CT Scanners Recalled for Image Artifacts During Specific Scans

    Philips is recalling 258 CT scanners because artifacts appear on images during threshold-triggered bolus scans using a 0.4-second rotation time.

    Product
    Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cros
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2013·2013-09-25

    Philips Brilliance CT Scanners Recalled for Footswitch Cover Defect

    Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.

    Product
    Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2013·2013-07-10

    Philips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality

    Philips is recalling Brilliance CT 64 and Ingenuity Core scanners due to software issues causing image artifacts that may impair diagnostic quality.

    Product
    Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2013·2013-07-03

    Philips CT Scanners Recalled for Patient Selection and Scan Safety Issues

    Philips Medical Systems is recalling 50 CT scanners due to a software defect that can cause incorrect patient names to appear on exam pages and allow clinical scans to start during anti-virus scans.

    Product
    Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2013·2013-06-12

    Philips Recalls BrightView SPECT Gamma Cameras Due to Mechanical Failure

    Philips Medical Systems is recalling 505 BrightView SPECT gamma cameras worldwide after a report of unexpected detector motion caused by a mechanical assembly failure.

    Product
    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed To
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1338-2013·2013-05-29

    Philips CT Systems Recall for Incorrect CTDIVol Data Storage

    Philips is recalling 515 CT systems because they stored the sum of CTDIVol values instead of individual slice values, resulting in incorrect data.

    Product
    Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Phil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2013·2013-04-24

    Philips IntelliSpace Portal Software Recall for URL PACS Integration Issue

    Philips is recalling IntelliSpace Portal software version 4.0.2 due to a display error when using URL PACS integration. The issue causes the Review monitor to display incorrect patient studies.

    Product
    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2013·2013-04-10

    Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks

    Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.

    Product
    Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0945-2013·2013-03-20

    Philips CT Systems Recalled for Patient Table Brake Malfunction

    Philips is recalling 4,797 CT systems because a vertical brake malfunction caused an unexpected downward movement of the patient table.

    Product
    Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0950-2013·2013-03-20

    Philips Brilliance 64 and Ingenuity CT Systems Software Update Recall

    Philips Medical Systems is recalling 42 Brilliance 64 and Ingenuity CT systems to update software and customer release notes.

    Product
    Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems 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 ang
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0906-2013·2013-03-13

    Philips CT System Software Recall for Incorrect Value Display

    Philips is recalling 2,580 Extended Brilliance Workspace CT systems to fix a software defect that may display incorrect values.

    Product
    Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstructi
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0883-2013·2013-03-06

    Philips GEMINI TF Big Bore PET/CT Systems Recalled for Software Error

    Philips is recalling 37 GEMINI TF Big Bore PET/CT systems because a software error may cause generated Intensity Projection data to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed To
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0899-2013·2013-03-06

    Philips MX 16-Slice CT Scanner Recall Due to Loose Table Screws

    Philips Medical Systems is recalling 412 MX 16-Slice CT Scanner Systems because loose screws may cause the patient table top to detach.

    Product
    Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0880-2013·2013-03-06

    Philips Brilliance CT Scanners Recalled for Software Data Flipping Error

    Philips is recalling Brilliance CT scanners because a software anomaly causes Intensity Projection datasets to be flipped and incorrectly labeled left-to-right.

    Product
    Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0897-2013·2013-03-06

    Philips Ingenuity TF PET/CT System Recalled for Gating Trigger Risk

    Philips Medical Systems is recalling one Ingenuity TF PET/CT unit in Ohio because the system may not default to the correct gating trigger, posing a risk to patients.

    Product
    Ingenuity TF PET/CT. Diagnostic imaging system
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0881-2013·2013-03-06

    Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners

    Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0882-2013·2013-03-06

    Philips GEMINI PET/CT Systems Recalled for Software Data Flipping Error

    Philips is recalling 30 GEMINI PET/CT systems because a software error causes Intensity Projection data to be flipped and mislabeled left-to-right.

    Product
    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0786-2013·2013-03-06

    Philips CT Systems Recalled for Deteriorating Image Quality Phantom Pins

    Philips Medical Systems is recalling 1,474 CT scanners because low-contrast pins in the Image Quality phantom deteriorate, preventing required daily checks.

    Product
    Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional i
    Category
    Medical Device
    Distribution
    Distributed nationwide