Mobilett Mira wireless (VA20) mobile x-ray system(s)
Reported: November 22, 2023 Initiated: October 5, 2023 #Z-0223-2024
Product Description
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 4 distributed in U.S.
- Distribution
- US Nationwide - Worldwide
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Mobilett Mira wireless (VA20) mobile x-ray system(s). Recalled by Siemens Medical Solutions USA, Inc. Units affected: 4 distributed in U.S..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0223-2024.
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