# FDA recall Z-0200-2022

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-09-24.

## Product

Artis zeego, Fluoroscopic X-Ray System  Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models:  Product/Model #:  syngo X Workplace, 10281061  syngo X Workplace, 10281299  syngo X Workplace, 10502522  Syngo Application Software, 10848815

## Reason for recall

Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0200-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-24
- **Report date:** 2021-11-10

- **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-0200-2022

## Citation

> AI Analytics. FDA recall Z-0200-2022. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0200-2022. Source: US FDA. Licensed CC0.

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