Recall Z-0737-2022— Philips Healthcare

Name: FDA recall Z-0737-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-02

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare, initiated 2022-02-02, terminated 2024-11-05. It names one FDA 510(k) clearance: K200917. 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..

Recalling firm: Philips Healthcare
Classification: Class II
Status: Terminated
Initiated: 2022-02-02
Terminated: 2024-11-05
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K200917 — Azurion R2.1Philips Medical Systems Nederland B.V.·cleared 2020-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.