# FDA recall Z-1764-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-04-06.

## Product

System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in sitting, standing, or supine positions.

## Reason for recall

It was determined that in rare cases persons can receive low dose of unintended radiation.  The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-1764-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-06
- **Report date:** 2020-05-13
- **Termination date:** 2020-10-27

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1764-2020

## Citation

> AI Analytics. FDA recall Z-1764-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1764-2020. Source: US FDA. Licensed CC0.

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