Urgent Field Safety Notice For Azurion By Philips Medical Systems Nederland B.v.

Azurion Recall Summary Philips Medical Systems Nederland B.V. has issued an urgent field safety notice for its Azurion medical device. The notice affects units distributed in Germany and the EU, though the specific reason for the recall is not clearly stated in the provided document. This is classified as a Class I safety issue, which is the most serious classification level.

Recalling firm

Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V. , Download_VeroeffentlichtAm_EN 2026.04

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B

Reason

assessment Field corrective actions Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-04-29

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/6ce05cd1-1952-4591-a5cc-1cfe87f83024