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
Recall
- Recall Number
- Z-1670-2025
- Event Number
- 96638
- Firm
- Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
- FEI Number
- 3012855798
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- April 4, 2025
- Posted
- April 24, 2025
Description
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
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
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: [email protected] and copy [email protected] 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.
US: NJ, WA, Puerto Rico OUS: None
5 units