Philips StentBoost Live R2 — Class II medical device recall Z-0737-2022
Terminated recall by Philips Healthcare, reported 2022-04-13, distributed nationwide. Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop au
| Recall number | Z-0737-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Healthcare, Andover, MA, United States |
| Recall initiated | 2022-02-02 |
| Classified | 2022-04-05 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 42 systems |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0737-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.