| | Class 2 Device Recall Rover |  |
| Date Initiated by Firm | April 04, 2025 |
|---|
| Date Posted | April 24, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1669-2025 |
|---|
| Recall Event ID |
96638 |
| 510(K)Number | K211423 |
|---|
| Product Classification |
System, x-ray, mobile - Product Code IZL
|
| Product | Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71, MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors.
The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas
Component: N/A |
|---|
| Code Information |
(Serial Number UDI-DI)
352 (01)09357123000051(11)230823(21)00352
334 (01)09357123000051(11)220921(21)00334
389 (01)09357123000051(11)230814(21)00383
383 (01)09357123000051(11)230814(21)00383
384 (01)09357123000051(11)230816(21)00384
382 (01)09357123000051(11)230809(21)00382
386 (01)09357123000051(11)230908(21)00386
385 (01)09357123000051(11)230906(21)00385
387 (01)09357123000051(11)230914(21)00387
388 (01)09357123000051(11)230916(21)00388
364 01)09357123000051(11)230705(21)00364
390 (01)09357123000051(11)231013(21)00390
395 (01)09357123000051(11)231106(21)00395
|
Recalling Firm/
Manufacturer |
Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia
|
| For Additional Information Contact |
206-2498764 |
|---|
Manufacturer Reason
for Recall | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | On April 4, 2025, Micro-X Ltd. issued a "Urgent Medical Device Correction" Notification to via E-Mail affected consignees. Micro-X ask consignees to take the following actions:
" Inspect your stock immediately and quarantine affected stock on hand to prevent further use.
" Circulate this notice to all users of this device so they are aware of the issue.
" If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them.
" Please retain this letter with your system(s) documentation.
" Please complete and return the attached response form to the Micro-X LTD in Australia: support@micro-x.com and copy djerkovic@micro-x.com to reconcile this process no later than 30 days from receipt. Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.
|
|---|
| Quantity in Commerce | 13 units |
|---|
| Distribution | US: NJ, WA, Puerto Rico
OUS: None |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = IZL
|
|---|
|
|
|
