Reported Aug 10, 2022 · Completed
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number374848-09
- UDI -DI Code00886874116982
- System Serial Numbers
505 of 505 codes
SK1521SK0614SK4114SL0615SL0724SK1178SK4098SL0719SL0066SK4353SK4821SK4939SK4099SL0673SL0734SL0736SK3010SL0682SK3857SK1277SK4326SL0666SK4169SK4155SK4327SK3033SK1537SK4100SK0917SK4001SL0581SK3340SK4156SK3870SL0744SK1918SK1227SK4129SK4061SK4152SK4301SK4215SK4217SL0625SK4380SK2459SK2460SK0990SK4146SK1942SK1403SK0071SK4219SK4175SK3391SK2484SK1103SK3389SK3405SK0396
- Amount recalled
- 505 generators
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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