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 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
This recall is currently active, issued April 16, 2025. It was issued by Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia.
- Recall Initiated
- March 28, 2025
- Posted
- April 16, 2025
- Recall Number
- Z-1579-2025
- Quantity
- 20 units
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Distribution
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
Lot / Code Info
Serial Number/UDI: MSN0348 (01)09357123000037(11)230123(21)00348; MSN0349 (01)09357123000037(11)230209(21)00349; MSN0351 (01)09357123000037(11)230413(21)00351; MSN0359 (01)09357123000037(11)231130(21)00359; MSN0361 (01)09357123000037(11)230503(21)00361; MSN0365 (01)09357123000037(11)230510(21)00365; MSN0391 (01)09357123000037(11)230929(21)00391; MSN0406 (01)09357123000037(11)240301(21)00406; MSN0416 (01)09357123000037(11)240429(21)00416; MSN0419 (01)09357123000037(11)240628(21)00419; MSN0428 (01)09357123000037(11)240823(21)00428; MSN0429 (01)09357123000037(11)240823(21)00429; MSN0430 (01)09357123000037(11)240824(21)00430; MSN0431 (01)09357123000037(11)240826(21)00431; MSN0432 (01)09357123000037(11)241108(21)00432; MSN0434 (01)09357123000037(11)241115(21)00434; MSN0435 (01)09357123000037(11)241118(21)00435; MSN0436 (01)09357123000037(11)241122(21)00436; MSN0437 (01)09357123000037(11)241125(21)00437; MSN0438 (01)09357123000037(11)250114(21)00438
Root Cause
Device Design
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.