Rover Mobile X-ray System recallZ-1918-2026 · Micro-X Ltd. · initiated Mar 27, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Micro-X Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1918-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 27, 2026
- Posted by the FDA
- Apr 22, 2026
- Recalling firm
- Micro-X Ltd.
- Quantity
- 32 units
- Product code
- IZL
- FDA submissions
- K211423
- Distribution
- US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Product description
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)7 recalls0 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls0 reports
Other devices under the same FDA submission
1 device cleared under K211423 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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