Recall Z-1426-2013— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2011-10-13, terminated 2013-05-30. It names one FDA 510(k) clearance: K090993. 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.. Reason: 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.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-10-13
- Terminated
- 2013-05-30
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's record- K090993 — INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.