Da Vinci Surgical Robot Recall, Devices Not Tested Properly

July 15, 2013 — Intuitive Surgical has issued a Da Vinci Surgical Robot recall because “factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.” The Class II recall affects about 30 devices.

The recall began when Intuitive Surgical sent an Urgent Device Correction Notice to customers on June 27, 2013. The letter identified the product, the problems, and steps to be taken by the customer.

The recalled product are components of the Endoscopic Instrument Control System. These instruments are scopes with a tiny camera attached to a long, thin tube that is used for viewing and examining inside the body. They may also have surgical instruments attached that are used in surgeries.

The following parts of the da Vinci Surgical Robot were recalled:

• Da Vinci Si Vision System Cart
• Da Vinci Si Surgeon Side Cart
• Da Vinci Instrument Control Box
• Da Vinci Dual Camera Controller