Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0737-2022 — Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

U.S. FDA — Device Enforcement · United States · 2022-02-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0737-2022
Date of alert
2022-02-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Healthcare
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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