FDA-Device2014-02-26Class II
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic
Integra LifeSciences Corp.
Hazard
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
Sold states
Worldwide Distribution - USA Nationwide
Affected count
17253 boxes
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0994-2014Don't want to check this manually?
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