Z-0737-2022 Class II Terminated
FDA device recall Z-0737-2022 was initiated by Philips Healthcare on February 2, 2022 and is designated Class II. Reason for recall: 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 Phili… The recall status is terminated (terminated November 5, 2024). Affected quantity: 42 Systems.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- February 2, 2022
- Termination Date
- November 5, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 42 Systems
Product Description
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Azurion R2.1