Micro-X Ltd.: 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

Hazard

Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.

Details from the source

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). Quantity: 20 units 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

UPC codes

09357123000037

Source

Official record: FDA (Device enforcement) ↗

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