FDA Medical devices recall ·
MICRO-X Rover Mobile X-ray System, # MXU-RV19 recall
- Recall number
- Z-0666-2025
- Date
- (initiated October 23, 2024)
- 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
- 23
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Why was it recalled?
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
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: 09357123000013. Serial Numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, 266.
Distribution
US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
States: Arizona California Idaho Ohio Texas Washington
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-0666-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.