Class 2 Device Recall MICROX Rover Mobile Xray System

• Date Initiated by Firm: May 31, 2023
• Date Posted: December 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0664-2025
• Recall Event ID: 95603
• 510(K)Number: K211423
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: MICRO-X Rover Mobile X-ray System, # MXU-RV35
• Code Information: UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
• FEI Number: 3012855798
• Recalling Firm/ Manufacturer: Micro-X Ltd.; Unit 14 6 Mab Eastern Promenade; Tonsley Australia
• For Additional Information Contact: +61405298471
• Manufacturer Reason for Recall: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
• FDA Determined Cause: Software design
• Action: The firm will notify consignees using a service bulletin that was already posted. Additionally, the firm will implement a firmware update to extend the timer (4 ms to 10 ms minimum) to ensure even short exposures achieve the necessary image quality for diagnostic use.
• Quantity in Commerce: 5
• Distribution: Worldwide and US Nationwide Distribution: NJ, PR, CA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IZL