Z-0121-2016Class II

Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100...

Name: Z-0121-2016 Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100...
Creator: Djo, Llc
Published: 2015-08-21
License: https://open.fda.gov/license/

DJO, LLC / initiated 2015-08-21 / Terminated / root cause: design

FDA source

DJO, LLC began a recall of Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the... on 2015-08-21. FDA classified it as Class II and gives the reason as "Overheating and burning of the wire insulation inside the applicator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0121-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-21
Posted: 2015-10-15
Terminated: 2016-10-24
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.
Product code: IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Reason for recall: Overheating and burning of the wire insulation inside the applicator.
Root cause tag: design
FDA 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 [email protected]. 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 [email protected].
Quantity in commerce: 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
Product codes and lots: Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0121-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-21	2015-10-14

Product code IMJ

K083433Class IIIntelect Swd 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Chattanooga Group / cleared 2009-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)