# FDA recall Z-2016-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-06-12.

## Product

AXIOM Artis BA, Model Number 5904656

## Reason for recall

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2016-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-12
- **Report date:** 2019-07-31
- **Termination date:** 2020-09-18

- **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-2016-2019

## Citation

> AI Analytics. FDA recall Z-2016-2019. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2016-2019. Source: US FDA. Licensed CC0.

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