Home / Recalls / Medical Devices
DJO, LLC recalls Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Inte
Recalled October 21, 2015 · FDA recall Z-0121-2016 · DJO
Hazard
Overheating and burning of the wire insulation inside the applicator. · FDA Class II
Units
2887
Sold at
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
Description
Overheating and burning of the wire insulation inside the applicator.
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.
Manufacturer(s)
DJO, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →