| Date Initiated by Firm | March 28, 2025 |
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| Date Posted | April 16, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1578-2025 |
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| Recall Event ID |
96518 |
| 510(K)Number | K211423 |
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| Product Classification |
System, x-ray, mobile - Product Code IZL
|
| Product | Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71
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 |
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| Code Information |
Serial Number/UDI:
MSN0334 (01)09357123000051(11)220921(21)00334;
MSN0350 (01)09357123000037(11)230328(21)00350 ;
MSN0352 (01)09357123000051(11)230823(21)00352;
MSN0364 01)09357123000051(11)230705(21)00364;
MSN0382 (01)09357123000051(11)230809(21)00382;
MSN0383 (01)09357123000051(11)230814(21)00383;
MSN0384 (01)09357123000051(11)230816(21)00384;
MSN0385 (01)09357123000051(11)230906(21)00385;
MSN0386 (01)09357123000051(11)230908(21)00386;
MSN0387 (01)09357123000051(11)230914(21)00387;
MSN0388 (01)09357123000051(11)230916(21)00388;
MSN0389 (01)09357123000051(11)230918(21)00389;
MSN0390 (01)09357123000051(11)231013(21)00390;
MSN0395 (01)09357123000051(11)231106(21)00395;
MSN0397 (01)09357123000051(11)231118(21)00397;
MSN0399 (01)09357123000051(11)240122(21)00399;
MSN0400 (01)09357123000051(11)240207(21)00400;
MSN0401 (01)09357123000051(11)240131(21)00401;
MSN0402 01)09357123000051(11)240202(21)00402;
MSN0403 (01)09357123000051(11)240205(21)00403;
MSN0405 (01)09357123000051(11)240206(21)00405;
MSN0408 (01)09357123000051(11)240308(21)00408;
MSN0409 (01)09357123000051(11)240312(21)00409;
MSN0410 (01)09357123000051(11)240318(21)00410;
MSN0411 (01)09357123000051(11)240319(21)00411;
MSN0422 (01)09357123000051(11)240724(21)00422;
MSN0423 (01)09357123000051(11)240808(21)00423;
MSN0424 (01)09357123000051(11)240809(21)00424;
MSN0425 (01)09357123000051(11)240812(21)00425;
MSN0426 (01)09357123000051(11)240812(21)00426;
MSN0427 (01)09357123000051(11)240812(21)00427;
|
| 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 | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. |
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FDA Determined
Cause 2 | Device Design |
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| Action | On March 28, 2025, Micro-X Ltd. issued a "Urgent: Medical Device Correction" notification to affected consignees via E-Mail. Micro-X asked consignees to take the following actions:
1. Continue to use your product as normal in accordance with its intended use.
2. Your local service representative will be in contact to apply this update to the systems at the next site visit.
3. Circulate this notice to all users of this device so they are aware of the issue.
4. If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them.
5. Please retain this letter with your system(s) documentation.
6. Please complete and return the attached response form to Micro-X to the Micro-X LTD in Australia: support@micro-x.com and copy djerkovic@micro-x.com.
|
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| Quantity in Commerce | 31 units |
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| Distribution | US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
|
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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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