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

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,…

Date

2022-04-13

Country

United States

Brand

Philips Healthcare

Product

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

Classification

Class II

Units

US Nationwide distribution.

Category

Drugs & medical

Source

FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

1. Check the product name, strength and lot number against the official notice.
2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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