Recall Z-1918-2026
Micro-X Ltd. · initiated March 27, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Codes / lots: Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462
Reason for recall
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
FDA-determined cause: Component design/selection
Action taken
On March 27, 2026, Micro-X issued a Urgent: Medical Device Correction Notification, via E-Mail. Micro-X ask consignees to take the following actions: " Contact your local service representative to arrange replacement of the PCBA with the updated version at the next scheduled visit or Preventative Maintenance. In the interim, customers may continue to use the device. " To minimize the likelihood of system failure, the batteries should not be permitted to fully discharge. Any system errors or abnormal behaviours must be reported to your authorised service provider without delay. " If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. " Please complete and email the Customer Response Form in Appendix 1 to the Micro-X LTD in Australia: djerkovic@micro-x.com and copy support@micro-x.com Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.
Details
- Recall number
- Z-1918-2026
- Initiated
- March 27, 2026
- Posted by FDA
- April 22, 2026
- Product code
- IZL – System, X-Ray, Mobile
- Quantity
- 32 units
- Distribution
- US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
- Recalling firm
- Micro-X Ltd., Tonsley