# FDA recall Z-3189-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-07-29.

## Product

Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

## Reason for recall

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit.  This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-3189-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-29
- **Report date:** 2018-09-26
- **Termination date:** 2019-05-17

- **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-3189-2018

## Citation

> AI Analytics. FDA recall Z-3189-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-3189-2018. Source: US FDA. Licensed CC0.

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