FDA Medical Device Recalls (openFDA)
Micro-X Ltd.: MICRO-X Rover Mobile X-ray System, # MXU-RV35
- Recall number
- Z-0580-2025
- Recalling firm
- Micro-X Ltd.
- Product
- MICRO-X Rover Mobile X-ray System, # MXU-RV35
- Status
- Open, Classified
- Initiated
- 2024-10-22
- Posted
- 2024-11-27
- Terminated
- not on file
- Reason
- Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
- Root cause
- Environmental control
- Action
- On 10/22/24, Service Bulletin SB007-23-1.0 was emailed to customers restating receiving, storage, and operation conditions and informing customers that extreme humidity environments can adversely affect the equipment. For further information contact your local service representative: phone: 1-206-249-8764 Email: support-us@micro-x.com
- Quantity
- 6
- Distribution
- US: TX, PR, MD, CA
- Lot, serial or model codes
- UDI-DI: 9357123000037, Serial Numbers: 348, 349, 361, 351, 365, 391
- 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