FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: 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.
- Recall number
- Z-1426-2013
- Recalling firm
- Intuitive Surgical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-10-13
- Posted
- 2013-05-29
- Terminated
- 2013-05-30
- Reason
- Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
- Root cause
- No Marketing Application
- Action
- Intuitive sent a notification letter on October 17, 2011 by email to all consigness whose email address were on file. Also a copy of the letter was sent by registered mail on February 8, 2012 to all surgeons whose addresses were on file. The letters informed consignees that Intuitive Surgical were in the process of reviewing labeling for the da Vinci System in regard to use for thyroidectomy procedures. During this period, Intuitive will not provide or facilitate any promotional, training, case observations, proctoring or in case procedural support for use of the da Vinci System in conjunction with thyroidectomy procedures. The letters recommend consulting the institution policy regarding use of approved or cleared medical devices for procedures that are not specified in the labeled indication for use. Questions may be directed to customer service at 1-877-408-3872.
- Quantity
- 2,423 consignee
- Distribution
- USA Nationwide distribution
- Lot, serial or model codes
- NA - marketing and promotional only.
- 510(k) numbers
- K090993
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28