Recall Z-1918-2026— Micro-X Ltd.

Name: FDA recall Z-1918-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Class II · Ongoing

Class II FDA medical device recall by Micro-X Ltd., initiated 2026-03-27. It names one FDA 510(k) clearance: K211423. Product: Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71. Reason: X-Ray generator may malfunction resulting in the X-Ray being inoperable..

Recalling firm: Micro-X Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2026-03-27
Firm location: Tonsley, N/A, Australia

510(k) clearances named in this recall

1 on FDA's record

K211423 — RoverMicro-X Limited·cleared 2021-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.