# FDA recall Z-1288-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-02-26.

## Product

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

## Reason for recall

Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

## Distribution

US Nationwide distribution in the states of MI, KY, TX.

## Key facts

- **Recall number:** Z-1288-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-26
- **Report date:** 2021-03-31
- **Termination date:** 2021-08-11

- **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-1288-2021

## Citation

> AI Analytics. FDA recall Z-1288-2021. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-1288-2021. Source: US FDA. Licensed CC0.

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