Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave...
FDA Device Recall #Z-0121-2016 — Class II — August 21, 2015
Recall Summary
| Recall Number | Z-0121-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DJO, LLC |
| Location | Vista, CA |
| Product Type | Devices |
| Quantity | 2887 |
Product Description
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.
Distribution Pattern
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 / Code Information
Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015
Other Recalls from DJO, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0722-2026 | Class II | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, ... | Sep 25, 2025 |
| Z-0010-2022 | Class I | Ultra-Myossage Lotion 1-gallon bottle, REF: 42... | Sep 7, 2021 |
| Z-0009-2022 | Class I | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/... | Sep 7, 2021 |
| Z-1985-2019 | Class II | Aircast REF 3011 - PL RX only VF-PL Sterile Cuf... | Jan 17, 2019 |
| Z-2590-2020 | Class II | This is an accessory to Intelect Advanced, Inte... | Jun 25, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.