| Date Initiated by Firm | March 27, 2026 |
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| Date Posted | April 22, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1918-2026 |
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| Recall Event ID |
98644 |
| 510(K)Number | K211423 |
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| Product Classification |
System, x-ray, mobile - Product Code IZL
|
| Product | Rover Mobile X-ray System
Model/Catalog Number: MXU-RV35 and MXU-RV71 |
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| Code Information |
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
|
| FEI Number |
3012855798
|
Recalling Firm/
Manufacturer |
Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia
|
| For Additional Information Contact |
206-2498764 |
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Manufacturer Reason
for Recall | X-Ray generator may malfunction resulting in the X-Ray being inoperable. |
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FDA Determined
Cause 2 | Component design/selection |
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| 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 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.
|
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| Quantity in Commerce | 32 units |
|---|
| Distribution | US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
|
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = IZL
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