FDA Device recall Z-0986-2022
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic…
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0986-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-25 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
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
Identifiers
| code_info | S/N: Serial 170319 170026 170343 170367 170368 170305 170360 170307 170331 170349 170309 170310 170361…S/N: Serial 170319 170026 170343 170367 170368 170305 170360 170307 170331 170349 170309 170310 170361 170351 170383 170023 170304 170328 170334 170336 170025 170346 170051 170358 170357 170333 170365 170332 170312 170027 170303 170378 170322 170053 170364 UDI: 04056869149325 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0986-2022%22
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