Conmed Corporation: Pediatric Dual Dispersive Electrodes (for patients 5-15 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 7-383. Intended to be used for the dispersion and return to the electrosurgical generator.

Recall number

Z-2599-2016

Recalling firm

Conmed Corporation

Product

Pediatric Dual Dispersive Electrodes (for patients 5-15 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 7-383. Intended to be used for the dispersion and return to the electrosurgical generator.

Status

Terminated

Initiated

2016-05-18

Posted

not on file

Terminated

2018-05-24

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.

Root cause

Device Design

Action

On May 17, 2016 CONMED Corporation distributed Urgent Device Recall notification letters and Business Reply Forms to their customers via courier service. CONMED Corporation has decided to recall these ThermoGard Dual Dispersive Electrodes for all customers who do not use an electrosurgical generator that employs the Contact Quality Monitoring systems listed. If your electrosurgical generator is not listed, your generator should not be used with the lot codes of the ThermoGard Dual Dispersive Electrodes identified. Customers are advised to inspect inventory for any of the recalled devices. If you use the ThermoGard Dual Dispersive Electrodes in conjunction with an electrosurgical generator listed, no further action is required. However, if your electrosurgical generator and CQM system is not listed above, do not use the affected lot codes of ThermoGard Dual Dispersive Electrodes. Please note that ThermoGard Dual Dispersive Electrodes produced after July 5, 2015, are not subject to this recall. Customers should contact all of those departments or organizations within their facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please contact Patricia Cotter, CONMED Recall Coordinator 315-624-3237 (8AM-5PM EST, M-F) or fax to 315-624-3225 or email thermog@CONMED.com.

Quantity

4,560 units

Distribution

Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.

Lot, serial or model codes

Beginning Lot Code 141001X with Ending Lot Code 20150705X.

510(k) numbers

["K140658"]

PMA numbers

not on file

Product code

GEI

Firm FEI

1317214

Firm city

Utica

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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