Recall Z-1918-2026 ยท IZL System, X-Ray, Mobile
Micro-X Ltd.
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
| Date | Apr 22, 2026 (initiated Mar 27, 2026) |
| Status | Open, Classified |
| Reason | X-Ray generator may malfunction resulting in the X-Ray being inoperable. |
| Root cause | Component design/selection |
| Action | 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 produ |
| Quantity | 32 units |
| Distribution | US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211423 | Rover Micro-X Limited, May 21, 2021 |