FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0121-2016
- Recalling firm
- DJO, LLC
- 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.
- Status
- Terminated
- Initiated
- 2015-08-21
- Posted
- 2015-10-15
- Terminated
- 2016-10-24
- 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 that customers will be sent an upgraded monode accessory along with a pre-paid shipper for the return of the current used unit. Any questions the letter states to contact Product Support per the contact information above or William Fisher, Global Regulatory Compliance at 760-734-3126. Letters sent to direct users received the same instruction of returning the product for a replacement. Any questions the letter states to call 877-733-4888 or email at monode.support@djoglobal.com.
- 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, Indonesia
- Lot, serial or model codes
- Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015
- 510(k) numbers
- ["K083433"]
- PMA numbers
- not on file
- Product code
- IMJ
- Firm FEI
- 2020737
- Firm city
- Vista
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28