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Recall Observatory FDA recall evidence

Device product

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.

Z-0121-2016

August 21, 2015

Class II

Product summary

Firm
DJO, LLC
Event
Event 72168
Status
Terminated
Classification
Class II
Quantity
2887
Official record key
device-enforcement:Z-0121-2016

Official wording

Reason: Overheating and burning of the wire insulation inside the applicator.

Code information: Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015

Distribution pattern: Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Overheating and burning of the wire insulation inside the applicator.