Artis icono biplane- in combination with a Siemens Healthineers table… — Class II medical device recall Z-0985-2022

Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-04-27, distributed nationwide. Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Hea

Recall number	`Z-0985-2022`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated	2022-02-25
Classified	2022-04-21
Reported by FDA	2022-04-27
Distributed	Nationwide (US)
Quantity	94 u.s
Reason classes	software
UPC / GTIN / UDI-DI	`04056869063317`
Model numbers	`11327600`

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

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0985-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.