Recall Z-0121-2016 ยท IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
DJO, LLC
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.
| Date | Oct 15, 2015 (initiated Aug 21, 2015) |
| Status | Terminated |
| Reason | Overheating and burning of the wire insulation inside the applicator. |
| Root cause | Device Design |
| Action | The firm sent out two customer notification letters; one to distributors and one to direct users. Letters were sent September 1, 2015 via USPS certified return receipt. Distributors were asked to obtain a list of their customers with contact information that have purchase or received the monode accessory or Intelect Shortwave device that included the monode as an accessory item. Once the list has been assembled the firm requests that it be forwarded to DJO Global Chattanooga Product Support by phone 877-733-4888, or by e-mail at monode.support@djoglobal.com. The firm's notification states |
| Quantity | 2887 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083433 | INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 Chattanooga Group, Mar 18, 2009 |