PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 27, 2022 Initiated: February 25, 2022 #Z-0985-2022

Product Description

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

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

Details

Units Affected
94 U.S.
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 94 U.S..
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0985-2022.

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