FDA Medical devices recall ·
MICRO-X Rover Mobile X-ray System, # MXU-RV35 recall
- Recall number
- Z-0665-2025
- Date
- (initiated November 28, 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
- 18
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Why was it recalled?
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
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
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
US Nationwide Distribution: NJ, CA, PR
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-0665-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.