Recall – Software error leads to limited functionality of surgical table

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.

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