Recall Z-1670-2025 ยท IZL System, X-Ray, Mobile
Micro-X Ltd.
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: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 d
| Date | Apr 24, 2025 (initiated Apr 4, 2025) |
| Status | Open, Classified |
| Reason | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. |
| Root cause | 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 |
| Quantity | 5 units |
| Distribution | US: NJ, WA, Puerto Rico OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211423 | Rover Micro-X Limited, May 21, 2021 |