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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.
June 8, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by
Hazard: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
June 8, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of th
Hazard: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
June 8, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of th
Hazard: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
June 8, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the bod
Hazard: The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
April 27, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides sof
Hazard: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
April 27, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro
Hazard: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
April 27, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software
Hazard: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
April 20, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reco
Hazard: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
April 20, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by compute
Hazard: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
April 20, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer
Hazard: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
April 20, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer
Hazard: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
April 20, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer re
Hazard: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
April 20, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer rec
Hazard: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
March 9, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Hazard: The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
March 9, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Hazard: The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
March 9, 2016Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Hazard: The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
December 30, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity CT Computed Tomography X-ray system
Hazard: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
December 30, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128 Computed Tomography X-ray system
Hazard: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
December 30, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core Computed Tomography X-ray system
Hazard: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
December 30, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT SP Computed Tomography X-ray system
Hazard: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
December 30, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Computed Tomography X-ray system
Hazard: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
December 30, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 Computed Tomography X-ray system
Hazard: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
December 16, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-s
Hazard: Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
December 16, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The pr
Hazard: Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
November 11, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomo
Hazard: The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
November 4, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Hazard: The firm discovered Ring/Dot artifact due to X-ray measurement error.
November 4, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional imag
Hazard: The firm discovered Ring/Dot artifact due to X-ray measurement error.
November 4, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Hazard: The firm discovered Ring/Dot artifact due to X-ray measurement error.
November 4, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Hazard: The firm discovered Ring/Dot artifact due to X-ray measurement error.
November 4, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Hazard: The firm discovered Ring/Dot artifact due to X-ray measurement error.