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THERMOGUARD DISPERSIVE ELECTRODES (2016-05-26)
- Starting date:
- May 26, 2016
- Posting date:
- June 16, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58894
Affected products
- THERMOGUARD DISPERSIVE ELECTRODES
Reason
A version of the ConMed ThermoGard Dual Dispersive Electrodes, manufactured between October 1, 2014, and July 5, 2015, may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. A customer alerted ConMed of this condition on April 6, 2016. These generators use a CQM (contact quality monitoring) technology which may rely on a preset upper limit (alarm limit) of the CQM impedance to detect pad lift. Please contact ConMed for a complete list of compatible CQM electrosurgical generators (esu's).
Affected products
A. THERMOGUARD DISPERSIVE ELECTRODES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 51-7310
- 7-382
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES