Philips Healthcare recalls Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

Recall date

February 2, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0737-2022

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x