Philips Healthcare: Medical Device Recall in 2022 - (Recall #: Z-0737-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 2, 2022

Date Posted: April 13, 2022

Recall Number: Z-0737-2022

Event ID: 89750

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.

Status: Terminated

Product Quantity: 42 Systems

Code Information:

Azurion R2.1

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

FDA Mandated