Da Vinci Surgical System recalled over fire hazard

Recall date

June 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Intuitive Surgical, Inc. recalls da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in t…

Recall number

Z-0283-2021

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

US Nationwide distribution including in the state of Washington.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.