FDA Medical devices recall ·
MICRO-X Rover Mobile X-ray System, # MXU-RV35 recall
- Recall number
- Z-0664-2025
- Date
- (initiated May 31, 2023)
- Company / brand
- Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade, Tonsley, Australia - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
Distribution
Worldwide and US Nationwide Distribution: NJ, PR, CA
States: California New Jersey Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0664-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.