Recall Z-2598-2016— Conmed Corporation
Class II · Terminated
Class II FDA medical device recall by Conmed Corporation, initiated 2016-05-18, terminated 2018-05-24. It names one FDA 510(k) clearance: K140658. Product: Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.. Reason: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn..
- Recalling firm
- Conmed Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-18
- Terminated
- 2018-05-24
- Firm location
- Utica, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.
Reason for recall
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Data sourced from openFDA. This site is unofficial and independent of the FDA.