Device 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.
Z-2599-2016
Product summary
- Event
- Event 73607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,560 units
- Official record key
device-enforcement:Z-2599-2016
Official wording
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.
Code information: Beginning Lot Code 141001X with Ending Lot Code 20150705X.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.