Z-0737-2022Class II

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

Name: Z-0737-2022 Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Creator: Philips Healthcare
Published: 2022-02-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-02-02 / Terminated

FDA source

Philips Healthcare began a recall of Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x on 2022-02-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0737-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-02
Posted: 2022-04-05
Terminated: 2024-11-05
Recalling firm: Philips North America LLC
Product: Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 2, 2022. Philips will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information contact your local Philips representative: 1-800-722-9377.
Quantity in commerce: 42 Systems
Distribution: US Nationwide distribution.
Product codes and lots: Azurion R2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0737-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0737-2022	Class II	Terminated	FDA Mandated	2022-04-13	2022-04-05

Product code OWB

K200917Class IIAzurion R2.1Philips Medical Systems Nederland B.V. / cleared 2020-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)