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.
Reported: August 10, 2022 Initiated: June 22, 2022 #Z-1484-2022
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 505 generators
- Distribution
- 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.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Intuitive Surgical, Inc.. Units affected: 505 generators.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2022. Severity: Moderate. Recall number: Z-1484-2022.
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