Reported Apr 13, 2022 · Terminated
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Philips Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
- Lot codes and dates
- Azurion R2.1
- Amount recalled
- 42 Systems
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Healthcare recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.