Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-ra
FDA device recall Z-1670-2025 · posted 2025-04-24 · Open, Classified
Recall details
- Recalling firm
- Micro-X Ltd.
- Reason for recall
- Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 5 units
- Distribution
- US: NJ, WA, Puerto Rico OUS: None
- Date initiated
- 2025-04-04
- Date posted
- 2025-04-24
- Location
- Tonsley, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Rover (K211423) | Micro-X Limited | 2021-05-21 |