DJO, LLC: Medical Device Recall in 2015 - (Recall #: Z-0121-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 21, 2015

Date Posted: October 21, 2015

Recall Number: Z-0121-2016

Event ID: 72168

Reason for Recall:

Overheating and burning of the wire insulation inside the applicator.

Status: Terminated

Product Quantity: 2887

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

Voluntary or Mandated:

Voluntary: Firm initiated