Reported Nov 21, 2018 · Terminated

RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic…

Virtual Imaging, Inc.

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: Virtual Imaging, Inc. · 720 S Powerline Rd Ste E · Deerfield Beach, FL · 33442-8156

Is this the product you have?

  • RadPRO(R) Mobile 40kW
  • Digital X-Ray System - ModelSM-40HF-B-D-C
  • Product UsageInstrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
Lot codes and dates
  • 253 of 253 codes

    • G61814
    • G60652
    • G60606
    • G62565
    • G62687
    • G62500
    • G62883
    • G62690
    • G62750
    • G62502
    • G62867
    • G62891
    • G62626
    • G63322
    • G63328
    • G62900
    • G62564
    • G62037
    • G62480
    • G36042
    • G36206
    • G36287
    • G36526
    • G36643
    • G37129
    • G37633
    • G37641
    • G38635
    • G38652
    • G38657
    • G39465
    • G39533
    • G39544
    • G39551
    • G39589
    • G39639
    • G39650
    • G39657
    • G39782
    • G39791
    • G39800
    • G39801
    • G39808
    • G39809
    • G39818
    • G40004
    • G40016
    • G40024
    • G40116
    • G40124
    • G40126
    • G40133
    • G40199
    • G40203
    • G40208
    • G40216
    • G40226
    • G41058
    • G41066
    • G41083
Amount recalled
253 units

Where it was sold

  • Nationwide

Why it was recalled

There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.

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

Notice updated Aug 19, 2020 · Data as of Sep 19, 5:35 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.