Urgent Field Safety Notice For Artis Icono By Siemens Healthcare Gmbh Advanced Therapies

Recall Summary Siemens Healthcare GmbH is issuing an urgent field safety notice for the Artis icono advanced therapy device. This is a Class I recall affecting devices distributed in Germany and the EU. The notice addresses a risk assessment issue requiring corrective field actions.

Recalling firm

Urgent Field Safety Notice for Artis icono by Siemens Healthcare GmbH Advanced Therapies , Download_VeroeffentlichtAm_EN

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Artis icono by Siemens Healthcare GmbH Advanced Therapies 2026

Reason

assessment Field corrective actions Urgent Field Safety Notice for Artis icono by Siemens Healthcare GmbH Advanced Therapies 2026

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-05-21

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/52765a2d-2367-4d12-aafd-de7a41596eee