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U.S. Department of Health and Human Services

Class 2 Device Recall MICROX Rover Mobile Xray System

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 Class 2 Device Recall MICROX Rover Mobile Xray Systemsee related information
Date Initiated by FirmNovember 28, 2023
Date PostedDecember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0665-2025
Recall Event ID 95617
510(K)NumberK211423 
Product Classification System, x-ray, mobile - Product Code IZL
ProductMICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Code Information 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
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		Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
FDA Determined
Cause 2		Device Design
ActionOn 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: support-us@micro-x.com, 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.
Quantity in Commerce18
DistributionUS Nationwide Distribution: NJ, CA, PR
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZL
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