Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Recall
- Recall Number
- Z-1918-2026
- Event Number
- 98644
- Firm
- Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
- FEI Number
- 3012855798
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- March 27, 2026
- Posted
- April 22, 2026
Description
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
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: [email protected] and copy [email protected] Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
32 units