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.
Reported: June 5, 2013 Initiated: October 13, 2011 #Z-1426-2013
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).
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 2,423 consignee
- Distribution
- USA Nationwide distribution
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Intuitive Surgical, Inc.. Units affected: 2,423 consignee.
Why was this product recalled? ▼
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1426-2013.
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