# FDA recall Z-1144-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-12-18.

## Product

ARTIS Icono biplane Model:11327600  ARTIS Icono floor system Model: 11327700   with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

## Reason for recall

Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential  issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause  procedures  to be terminated and performed on an alternative x-ray system

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1144-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-18
- **Report date:** 2021-03-03
- **Termination date:** 2021-11-17

- **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-1144-2021

## Citation

> AI Analytics. FDA recall Z-1144-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1144-2021. Source: US FDA. Licensed CC0.

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