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 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
Enforcement
- Recall Number
- Z-1578-2025
- Event ID
- 96518
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Micro-X Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 23, 2025
- Initiation Date
- March 28, 2025
- Classification Date
- April 16, 2025
- Address
- Unit 14 6 Mab Eastern Promenade, Tonsley, N/A, Australia
Description
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 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 early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
Serial Number/UDI: MSN0334 (01)09357123000051(11)220921(21)00334; MSN0350 (01)09357123000037(11)230328(21)00350 ; MSN0352 (01)09357123000051(11)230823(21)00352; MSN0364 01)09357123000051(11)230705(21)00364; MSN0382 (01)09357123000051(11)230809(21)00382; MSN0383 (01)09357123000051(11)230814(21)00383; MSN0384 (01)09357123000051(11)230816(21)00384; MSN0385 (01)09357123000051(11)230906(21)00385; MSN0386 (01)09357123000051(11)230908(21)00386; MSN0387 (01)09357123000051(11)230914(21)00387; MSN0388 (01)09357123000051(11)230916(21)00388; MSN0389 (01)09357123000051(11)230918(21)00389; MSN0390 (01)09357123000051(11)231013(21)00390; MSN0395 (01)09357123000051(11)231106(21)00395; MSN0397 (01)09357123000051(11)231118(21)00397; MSN0399 (01)09357123000051(11)240122(21)00399; MSN0400 (01)09357123000051(11)240207(21)00400; MSN0401 (01)09357123000051(11)240131(21)00401; MSN0402 01)09357123000051(11)240202(21)00402; MSN0403 (01)09357123000051(11)240205(21)00403; MSN0405 (01)09357123000051(11)240206(21)00405; MSN0408 (01)09357123000051(11)240308(21)00408; MSN0409 (01)09357123000051(11)240312(21)00409; MSN0410 (01)09357123000051(11)240318(21)00410; MSN0411 (01)09357123000051(11)240319(21)00411; MSN0422 (01)09357123000051(11)240724(21)00422; MSN0423 (01)09357123000051(11)240808(21)00423; MSN0424 (01)09357123000051(11)240809(21)00424; MSN0425 (01)09357123000051(11)240812(21)00425; MSN0426 (01)09357123000051(11)240812(21)00426; MSN0427 (01)09357123000051(11)240812(21)00427;
US Nationwide distribution in the states of CA, NJ, and Puerto Rico (US territory).
31 units