# FDA recall Z-0223-2024

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2023-10-05.

## Product

Mobilett Mira wireless (VA20) mobile x-ray system(s)

## Reason for recall

Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.

## Distribution

US Nationwide - Worldwide

## Key facts

- **Recall number:** Z-0223-2024
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-05
- **Report date:** 2023-11-22

- **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-0223-2024

## Citation

> MORVS. FDA recall Z-0223-2024. Retrieved 2026-10-22 from https://api.morvs.ai/recall/Z-0223-2024. Source: US FDA. Licensed CC0.

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