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Philips Medical Systems FDA Recalls
11 recalls on file across devices, 0 of them Class I and 11 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CTClass IIJun 11, 2026The clinical CT scan may not automatically trigger after the |
| Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 UpgradesClass IIJun 11, 2026The clinical CT scan may not automatically trigger after the |
| IQon Spectral CT IQon Spectral CT UpgradesClass IIJun 11, 2026The clinical CT scan may not automatically trigger after the |
| Philips Spectral CT on Rails. Model Number: 728334.Class IIMar 7, 2026Philips has identified three software issues: 1. During a c |
| Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;Class IISep 25, 2025Issue 1: The potential for unintentional continued gantry/co |
| Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;Class IISep 25, 2025Issue 1: The potential for unintentional continued gantry/co |
| Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;Class IISep 25, 2025Issue 1: The potential for unintentional continued gantry/co |
| Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.Class IIDec 13, 2023A software issue that can incorrectly label all captured ima |
| Spectral CT on Rails: Software Version 5.1.0.X, model 728334.Class IIDec 13, 2023A software issue that can incorrectly label all captured ima |
| CombiDiagnost R90 1.0 (709030)Class IIFeb 11, 2022While performing a fluoroscopy examination, there is a poten |
| CombiDiagnost R90 1.1 (709031)Class IIFeb 11, 2022While performing a fluoroscopy examination, there is a poten |