# FDA recall Z-2029-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-05-27.

## Product

ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Model:   10849000

## Reason for recall

Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-2029-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-27
- **Report date:** 2021-07-14

- **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-2029-2021

## Citation

> AI Analytics. FDA recall Z-2029-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2029-2021. Source: US FDA. Licensed CC0.

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