Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1426-2013 — 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

U.S. FDA — Device Enforcement · United States · 2011-10-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1426-2013
Date of alert: 2011-10-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Intuitive Surgical, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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