Micro-X Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0665-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

Product Classification:

Class II

Date Initiated: November 28, 2023

Date Posted: December 18, 2024

Recall Number: Z-0665-2025

Event ID: 95617

Reason for Recall:

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

Status: Ongoing

Product Quantity: 18

Code Information:

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

Distribution Pattern:

US Nationwide Distribution: NJ, CA, PR

Voluntary or Mandated:

Voluntary: Firm initiated