# FDA recall Z-0108-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-08-03.

## Product

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures.    System Name/Material Number:  Artis Q BIPLANE	10848282  ARTIS Q CEILING	10848281  Artis Q floor	10848280  ARTIS Q ZEEGO	10848283  ARTIS Q.ZEN BIPLANE	10848355  ARTIS Q.zen ceiling	10848354  Artis Q.zen floor	10848353  Artis zee Biplane	10094141  Artis zee ceiling	10094137  Artis zee floor	10094135  Artis zee floor	10094135  Artis zee multi-purpose	10094139  Artis zeego	10280959

## Reason for recall

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

## Distribution

US Natonwide distribution.

## Key facts

- **Recall number:** Z-0108-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-03
- **Report date:** 2020-10-21
- **Termination date:** 2021-02-03

- **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-0108-2021

## Citation

> AI Analytics. FDA recall Z-0108-2021. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0108-2021. Source: US FDA. Licensed CC0.

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