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U.S. Department of Health and Human Services

Class 2 Device Recall Rover

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 Class 2 Device Recall Roversee related information
Date Initiated by FirmApril 04, 2025
Date PostedApril 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1670-2025
Recall Event ID 96638
510(K)NumberK211423 
Product Classification System, x-ray, mobile - Product Code IZL
ProductBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
Code Information Serial Number/UDI-DI - 349 (01)09357123000037(11)230209(21)00349 348 (01)09357123000037(11)230123(21)00348 350 (01)09357123000037(11)230328(21)00350. 351 (01)09357123000037(11)230413(21)00351 361 (01)09357123000037(11)230503(21)00361
Recalling Firm/
Manufacturer		 Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade
Tonsley Australia
For Additional Information Contact
206-2498764
Manufacturer Reason
for Recall		Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
FDA Determined
Cause 2		Device Design
ActionOn April 4, 2025, Micro-X Ltd. issued a "Urgent Medical Device Correction" Notification to via E-Mail affected consignees. Micro-X ask consignees to take the following actions: " Inspect your stock immediately and quarantine affected stock on hand to prevent further use. " Circulate this notice to all users of this device so they are aware of the issue. " If the product has been further distributed to other facilities, please ensure this notice is immediately shared with them. " Please retain this letter with your system(s) documentation. " Please complete and return the attached response form to the Micro-X LTD in Australia: support@micro-x.com and copy djerkovic@micro-x.com to reconcile this process no later than 30 days from receipt. Completing this form confirms receipt of this notice, understanding of the issue, and the necessary actions to be taken.
Quantity in Commerce5 units
DistributionUS: NJ, WA, Puerto Rico OUS: None
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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