Monode — Class II medical device recall Z-0121-2016
Terminated recall by DJO, LLC, reported 2015-10-21, distributed nationwide. Overheating and burning of the wire insulation inside the applicator.
| Recall number | Z-0121-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DJO, LLC, Vista, CA, United States |
| Recall initiated | 2015-08-21 |
| Classified | 2015-10-14 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2016-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BO, CL, CN, EC, ID, IL, KR, NI, PE, SV |
| Quantity | 2,887 |
| Reason classes | device malfunction |
| Model numbers | 02200002 |
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.
Reason for recall
Overheating and burning of the wire insulation inside the applicator.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0121-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.