FDA recall Z-1918-2026

Micro-X Ltd. · Class II · device

Product

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Reason for recall

X-Ray generator may malfunction resulting in the X-Ray being inoperable.

Distribution

US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2026-03-27
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tonsley, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2026