Intuitive Surgical, Inc. recalls Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally

Recalled June 5, 2013 · FDA recall Z-1426-2013 · Intuitive Surgical

Hazard

Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k). · FDA Class II

Units

2,423 consignee

Sold at

USA Nationwide distribution

Description

Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

Product

Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.

Manufacturer(s)

Intuitive Surgical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →