Reported Dec 18, 2024 · Ongoing

MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

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-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Lot codes and dates
  • MXU-RV35 UDI-DI9357123000037
  • 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
Amount recalled
18

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

Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

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, 7:35 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.