FDA Device recall Z-0737-2022
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x by Philips Healthcare, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0737-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-02 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Reason
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.
Identifiers
| code_info | Azurion R2.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0737-2022%22
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