Micro-X Ltd.: MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Hazard

Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

Details from the source

Reason for recall: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. Distribution: US Nationwide Distribution: NJ, CA, PR Quantity: 18 Lot/code info: MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395

UPC codes

9357123000037, 935712300005

Source

Official record: FDA (Device enforcement) ↗

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