DJO Monode Shortwave Accessory Recalled for Overheating and Burning Insulation
DJO, LLC is recalling Monode Shortwave Accessories due to overheating and burning of the wire insulation inside the applicator.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (burns from overheating) where specific injury counts are not reported in the source text, fitting the 'High' severity criteria for unreported injury risks.
Plain-English summary
DJO, LLC is recalling the Monode Shortwave Accessory, Model # 02200002. This accessory is used with the Intelect Shortwave Diathermy 100 and 400 units to apply electromagnetic energy for deep heat therapy. The recall involves 2,887 units that were distributed worldwide, including in the United States and several international countries.
The recall is being issued because of overheating and burning of the wire insulation inside the applicator. This defect poses a risk of injury to patients or users. The affected units are those received from the manufacturer prior to the week of July 12, 2015.
Healthcare facilities and users should stop using the affected Monode Shortwave Accessories immediately. They should contact DJO, LLC for instructions on how to return the product for repair or replacement.
The recalled product
- 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…
- Manufacturer
- DJO, LLC
- Hazard
- Affected units
- 2,887
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2015
Distribution
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