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

Recall Z-1967-2014 — Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

U.S. FDA — Device Enforcement · United States · 2014-05-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1967-2014
Date of alert: 2014-05-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Intuitive Surgical, Inc.
Product category: device
Product type: Devices

Reported risk: Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.

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

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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.

Recall Z-1967-2014 — Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

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