Reported Nov 4, 2020 · Terminated
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in…
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?
- da Vinci Surgical System, IS 4000; Endoscope Controller
- Model Number372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart
- Model Number381121-31 (UDI 00886874110898) -
- Product Usageused with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures
- Lot codes and dates
- IS4000 Endoscope Controller
- Serial Number432242 installed on the da Vinci Surgical System
- Serial NumberSK2137
- Amount recalled
- 1 system
Where it was sold
- Nationwide
- WA
Why it was recalled
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
This product could cause temporary or reversible health problems — stop using it.
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