# FDA recall Z-0987-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-02-25.

## 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 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0987-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-25
- **Report date:** 2022-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0987-2022

## Citation

> AI Analytics. FDA recall Z-0987-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0987-2022. Source: US FDA. Licensed CC0.

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