medical Class II Updated 2020-11-04

Intuitive Surgical, Inc. recalls da Vinci Surgical System, IS 4000; Endoscope Controller, Mod

Recalled Product

da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137
View official government recall

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