FDA-Device2022-08-10Class II
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.
Intuitive Surgical, Inc.
Hazard
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of Belgium, Denmark, Germany, Japan, Italy, Monaco, Norway, Sweden, Switzerland, United Kingdom.
Affected count
505 generators
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2022Don't want to check this manually?
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