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FDAMay 18, 2016device

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, Catalo...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

conmed

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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