Recall Z-0987-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0987-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-25

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-02-25. It names one FDA 510(k) clearance: K201156. Product: Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000. 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 movements 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: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-02-25
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K201156 — ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.·cleared 2020-06-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Reason for recall

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 movements 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.