FDA Medical Device Recalls (openFDA)
Micro-X Ltd.: MICRO-X Rover Mobile X-ray System, # MXU-RV35
- Recall number
- Z-0664-2025
- Recalling firm
- Micro-X Ltd.
- Product
- MICRO-X Rover Mobile X-ray System, # MXU-RV35
- Status
- Open, Classified
- Initiated
- 2023-05-31
- Posted
- 2024-12-12
- Terminated
- not on file
- Reason
- Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
- Root cause
- Software design
- Action
- The firm will notify consignees using a service bulletin that was already posted. Additionally, the firm will implement a firmware update to extend the timer (4 ms to 10 ms minimum) to ensure even short exposures achieve the necessary image quality for diagnostic use.
- Quantity
- 5
- Distribution
- Worldwide and US Nationwide Distribution: NJ, PR, CA
- Lot, serial or model codes
- UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
- 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