CLASS II Device recall · Reported 21 Oct 2015 · FDA Enforcement Report

Monode, Shortwave Accessory recalled by DJO

DJO is recalling Monode, Shortwave Accessory, distributed nationwide in the US. The recall was initiated on 21 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #: 02200002 All units received from the manufacture prior to the week of July 12, 2015

Quantity recalled2887

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0121-2016
FDA event ID: 72168
Recalling firm: DJO, Vista, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 Aug 2015
FDA classified: 14 Oct 2015
Reported: 21 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Aug 2015	Recall initiated by company
14 Oct 2015	Classified by FDA	+54 days
21 Oct 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Overheating and burning of the wire insulation inside the applicator.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alaska Arkansas Arizona California Colorado Florida Georgia Idaho Illinois Indiana Kansas Kentucky Massachusetts Michigan Minnesota Missouri North Carolina Nebraska New Hampshire New Jersey

Questions about this recall

Why was it recalled?

Overheating and burning of the wire insulation inside the applicator.

Which lots are affected?

Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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