FDA Device recall Z-0121-2016
Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diatherm…
- FDA Device
- Class II
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class II recall of Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diatherm… by Djo, citing overheating and burning of the wire insulation inside the applicator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0121-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-21 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Djo |
| Distribution | US |
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
Overheating and burning of the wire insulation inside the applicator.
Identifiers
| code_info | Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0121-2016%22
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