Urgent Field Safety Notice For O-arm O2 Imaging System By Medtronic Navigation Inc.

O-ARM O2 Imaging System Recall Summary Medtronic Navigation Inc. has issued a Class I urgent field safety notice for the O-ARM O2 imaging system. The notice affects devices distributed in Germany and the EU, though the specific reason for the recall is not clearly detailed in the available information. This is the most serious type of recall classification.

Recalling firm

Urgent Field Safety Notice for O-ARM O2 Imaging System by Medtronic Navigation Inc. , Download_VeroeffentlichtAm_EN 2026

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for O-ARM O2 Imaging System by Medtronic Navigation Inc

Reason

assessment Field corrective actions Urgent Field Safety Notice for O-ARM O2 Imaging System by Medtronic Navigation Inc

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-05-27

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/e915ba4e-b917-4cb9-940a-7d05a6f5f745