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
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
Overheating and burning of the wire insulation inside the applicator.