Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
FDA device recall Z-1918-2026 · posted 2026-04-22 · Open, Classified
Recall details
- Recalling firm
- Micro-X Ltd.
- Reason for recall
- X-Ray generator may malfunction resulting in the X-Ray being inoperable.
- 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.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 32 units
- Distribution
- US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
- Date initiated
- 2026-03-27
- Date posted
- 2026-04-22
- Location
- Tonsley, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Rover (K211423) | Micro-X Limited | 2021-05-21 |