FDA Medical Device Recalls (openFDA)
Micro-X Ltd.: MICRO-X Rover Mobile X-ray System, # MXU-RV19
- Recall number
- Z-0666-2025
- Recalling firm
- Micro-X Ltd.
- Product
- MICRO-X Rover Mobile X-ray System, # MXU-RV19
- Status
- Open, Classified
- Initiated
- 2024-10-23
- Posted
- 2024-12-12
- Terminated
- not on file
- Reason
- During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
- Root cause
- Device Design
- Action
- Starting on 10/23/24 Service Bulletin SB002-22 was sent to customers informing them that a field upgrade was released for the installation of an exposure switch holder. Customers were asked to complete and return an acknowledgement response form to support-us@micro-x.com For further information, contact your local service representative at support-us@micro-x.com, 1-206-249-8764.
- Quantity
- 23
- Distribution
- US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
- Lot, serial or model codes
- UDI-DI: 09357123000013. Serial Numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, 266.
- 510(k) numbers
- ["K211423"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3012855798
- Firm city
- Tonsley
- Firm state
- not on file
- Firm country
- Australia
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