Reported Dec 18, 2024 · Ongoing

MICRO-X Rover Mobile X-ray System, # MXU-RV19

Micro-X Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Micro-X Ltd. · Unit 14 6 Mab Eastern Promenade · Tonsley · N/A

Is this the product you have?

  • MICRO-X Rover Mobile X-ray System, # MXU-RV19
Lot codes and dates
  • UDI-DI09357123000013
  • 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
Amount recalled
23

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.