# FDA recall Z-0737-2022

> **Philips Healthcare** · Class II · device recall initiated 2022-02-02.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0737-2022
- **Recalling firm:** Philips Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-02
- **Report date:** 2022-04-13
- **Termination date:** 2024-11-05

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0737-2022

## Citation

> AI Analytics. FDA recall Z-0737-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0737-2022. Source: US FDA. Licensed CC0.

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