Philips StentBoost Live R2.0 application recall
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Why was Philips StentBoost Live R2.0 application recalled?
Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Azurion R2.1
- Product
- Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
- Recalling firm
- Philips Healthcare
- Quantity
- 42 Systems
- Distribution
- US Nationwide distribution.
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)