FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Mobilett Mira wireless (VA20) mobile x-ray system(s)
- Recall number
- Z-0223-2024
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Mobilett Mira wireless (VA20) mobile x-ray system(s)
- Status
- Open, Classified
- Initiated
- 2023-10-05
- Posted
- 2023-11-14
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Customer notification by means of a Customer Safety Advisory Notice (via electronic mail or FedEx) alerting customers to the lack of acoustic signal issue and providing instructions to monitor the visual indicator (exposure LED light) to avoid additional, unnecessary x-ray dose. The CSAN also includes the plan for the affected D810 boards. The boards (containing the faulty mounting of the buzzer) will be replaced, free of charge, at the customer site with field corrective action XP042/23/P. There is no software update.
- Quantity
- 4 distributed in U.S.
- Distribution
- US Nationwide - Worldwide
- Lot, serial or model codes
- Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
- 510(k) numbers
- ["K111912"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28