Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidec...
FDA Recall #Z-1426-2013 — Class II — October 13, 2011
Product Description
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.
Reason for Recall
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Recalling Firm
Intuitive Surgical, Inc. — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,423 consignee
Distribution
USA Nationwide distribution
Code Information
NA - marketing and promotional only.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated