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Philips Healthcare FDA Recalls
7 recalls on file across devices, 0 of them Class I and 5 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 |
|---|
| Incisive CT, software version 5.0Class IIAug 2, 2023Philips has identified three software issues with compliance |
| Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.xClass IIFeb 2, 2022Due to an incorrect configuration setting in the EPX databas |
| Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)Class IISep 24, 20213D-RA is a reconstruction software product that can be used |
| ProxiDiagnost N90 is multi-functional general R/F systems.Class IISep 22, 2021The Aleva monitor requires certain labels to be applied, som |
| CombiDiagnost R90 is multi-functional general R/F systems.Class IISep 22, 2021The Aleva monitor requires certain labels to be applied, som |
| DigitalDiagnost C90Class IISep 22, 2021The Aleva monitor requires certain labels to be applied, som |
| Azurion systems with software release R2.0.xClass IIMay 26, 2021In the Azurion system, the user can add a new study to a pat |