FDA Recall
Open, Classified
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Recall: Z-0665-2025
·
Initiated November 28, 2023
Recall
- Recall Number
- Z-0665-2025
- Event Number
- 95617
- Firm
- Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia
- FEI Number
- 3012855798
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- November 28, 2023
- Posted
- December 12, 2024
Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Reason
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Action
On 11/28/23 Modification 17 was sent to customers telling them that Control Boards need to be replaced with Control Board PCBA, 12425-04 that will eliminate the issue. For technical assistance contact: [email protected], 1-206-249-8764 Firm asked distributors to do the following: On next visit please confirm that the bulletins were completed and return the documentation.
Distribution
US Nationwide Distribution: NJ, CA, PR
Quantity
18