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RecallWatchMedical Device Safety
Class IIOngoingZ-1670-2025

Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Pr…

Micro-X Ltd.Tonsley, AustraliaReported Apr 30, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Brand 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
    5 affected lots
    349348350351361

What the firm is doing

On 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.

DistributionShow details

US: NJ, WA, Puerto Rico OUS: None

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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