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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 FirmOctober 23, 2024
Date PostedDecember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0666-2025
Recall Event ID 95593
510(K)NumberK211423 
Product Classification System, x-ray, mobile - Product Code IZL
ProductMICRO-X Rover Mobile X-ray System, # MXU-RV19
Code Information 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.
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		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.
FDA Determined
Cause 2		Device Design
ActionStarting on 10/23/24 Service Bulletin SB002-22 was sent to customers informing them that a field upgrade was released for the installation of an exposure switch holder. Customers were asked to complete and return an acknowledgement response form to support-us@micro-x.com For further information, contact your local service representative at support-us@micro-x.com, 1-206-249-8764.
Quantity in Commerce23
DistributionUS Nationwide Distribution: TX, CA, OH, ID, WA, AZ
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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