Recall Z-1578-2025 ยท IZL System, X-Ray, Mobile
Micro-X Ltd.
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
| Date | Apr 16, 2025 (initiated Mar 28, 2025) |
| Status | Open, Classified |
| Reason | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. |
| Root cause | Device Design |
| 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. Pl |
| Quantity | 31 units |
| Distribution | US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211423 | Rover Micro-X Limited, May 21, 2021 |