Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-r
FDA device recall Z-1578-2025 · posted 2025-04-16 · Open, Classified
Recall details
- Recalling firm
- Micro-X Ltd.
- Reason for recall
- Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 31 units
- Distribution
- US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
- Date initiated
- 2025-03-28
- Date posted
- 2025-04-16
- Location
- Tonsley, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Rover (K211423) | Micro-X Limited | 2021-05-21 |