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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.
November 4, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 16-Slice (Air) 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.
September 9, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Hazard: Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
August 5, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by co
Hazard: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
August 5, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by compu
Hazard: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
August 5, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cross-sectional images of the body by computer
Hazard: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
August 5, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by comput
Hazard: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
August 5, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional imag
Hazard: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
August 5, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-section
Hazard: 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation missing for some images when manual contrast was administered. Dot artifact present, intermittently, after startup. Heart Rate measured value incorrectly remains constant for some heart rate change conditions. DoseRight incorrectly enabled when the Exam Card specified disabling DoseRight. Tube heat predict
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
Hazard: A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional im
Hazard: A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images
Hazard: A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-r
Hazard: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray C
Hazard: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray
Hazard: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-r
Hazard: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-r
Hazard: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Compu
Hazard: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
July 29, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-
Hazard: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic I
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Ima
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnost
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and D
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and D
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Ima
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Ima
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray syste
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
June 17, 2015Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagno
Hazard: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.