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FDA (Device enforcement)Recalled 2025-04-04class ii

Micro-X Ltd.: Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that inc

Hazard

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Details from the source

Reason for recall: Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Distribution: US: NJ, WA, Puerto Rico OUS: None Quantity: 13 units Lot/code info: (Serial Number UDI-DI) 352 (01)09357123000051(11)230823(21)00352 334 (01)09357123000051(11)220921(21)00334 389 (01)09357123000051(11)230814(21)00383 383 (01)09357123000051(11)230814(21)00383 384 (01)09357123000051(11)230816(21)00384 382 (01)09357123000051(11)230809(21)00382 386 (01)09357123000051(11)230908(21)00386 385 (01)09357123000051(11)230906(21)00385 387 (01)09357123000051(11)230914(21)00387 388 (01)09357123000051(11)230916(21)00388 364 01)09357123000051(11)230705(21)00364 390 (01)09357123000051(11)231013(21)00390 395 (01)09357123000051(11)231106(21)00395

UPC codes

09357123000051

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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