Reported Oct 21, 2015 · Terminated

Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and…

Djo, LLC

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: DJO, LLC · 1430 Decision St · Vista, CA · 92081-8553

Is this the product you have?

  • Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.
Lot codes and dates
  • Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015
Amount recalled
2887

Where it was sold

Why it was recalled

Overheating and burning of the wire insulation inside the applicator.

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 Oct 24, 2016 · Data as of Sep 19, 4:15 PM UTC

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