Z-0121-2016 Class II Terminated
FDA device recall Z-0121-2016 was initiated by DJO, LLC on August 21, 2015 and is designated Class II. Reason for recall: Overheating and burning of the wire insulation inside the applicator. The recall status is terminated (terminated October 24, 2016). Affected quantity: 2887.
Recall Details
- Product Type
- Devices
- Report Date
- October 21, 2015
- Initiation Date
- August 21, 2015
- Termination Date
- October 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2887
Product Description
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.
Reason for Recall
Overheating and burning of the wire insulation inside the applicator.
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
Code Information
Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015