Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 4/27/2022
Class II
PRODUCT
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Recall Number:
Z-0985-2022
REASON
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movement function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. on 4/27/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
94 U.S.
DISTRIBUTION
US Nationwide.