Z-0223-2024 Class II Ongoing
FDA device recall Z-0223-2024 was initiated by Siemens Medical Solutions USA, Inc on October 5, 2023 and is designated Class II. 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 a… The recall status is ongoing. Affected quantity: 4 distributed in U.S..
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2023
- Initiation Date
- October 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 4 distributed in U.S.
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.
Distribution Pattern
US Nationwide - Worldwide
Code Information
Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633