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Philips Medical Systems (Cleveland) Recalls
315 recalls on record · June 20, 2012 to September 24, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 12, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector
Hazard: The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
March 29, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images o
Hazard: Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
March 29, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of
Hazard: When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
March 22, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls 882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addit
Hazard: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
March 22, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls 882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In additio
Hazard: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
March 22, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommod
Hazard: Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
February 22, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView X upgraded to XCT 882454
Hazard: The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
February 22, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView XCT
Hazard: The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
February 1, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT
Hazard: During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
January 18, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray Syst
Hazard: Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
January 18, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic exa
Hazard: There's a potential for liquid penetration into the back side of the front control panel of the X-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.
January 18, 2017Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the b
Hazard: Failure to correctly document the installation of four M12 Bolts into the system rotor.
December 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectru
Hazard: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
December 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by compute
Hazard: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
December 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by compute
Hazard: Software error due to the filament on timer
December 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128 728323
Hazard: Software error due to the filament on timer
December 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by compu
Hazard: Software error due to the filament on timer
December 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by comput
Hazard: Software error due to the filament on timer
December 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by comput
Hazard: Software error due to the filament on timer
November 23, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls IQon Spectral CT Computed Tomography X-ray system, Model 728332
Hazard: The product label does not include the correct current rating.
November 23, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core Computed Tomography X-ray system, Model 728321
Hazard: The product label does not include the correct current rating.
November 23, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
Hazard: The product label does not include the correct current rating.
November 23, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity CT Computed Tomography X-ray system, Model 728326
Hazard: The product label does not include the correct current rating.
November 23, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Hazard: The product label does not include the correct current rating.
November 23, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Computed Tomography X-ray system, Model 728306
Hazard: The product label does not include the correct current rating.
September 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView XCT Upgrade Model 882454
Hazard: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
September 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Hazard: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
September 14, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Hazard: The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
August 31, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-se
Hazard: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
August 31, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-secti
Hazard: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.