The Recall Desk
ModerateFDA (Devices)·Z-1974-2014·Announced 2014-07-09

Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides

Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from the documentation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text describes a documentation update to remove a specific tool from the guide, which aligns with the criteria for moderate severity involving labeling or documentation issues.

Plain-English summary

Intuitive Surgical, Inc. is recalling Quick Reference Guides (QRG) for the da Vinci Standard Surgical System, da Vinci S System, and da Vinci Si System. The recall involves the removal of the Emergency Grip Release Wrench, part number 710142, from the documentation.

The recall covers all distributed units prior to June 2014. The affected products were distributed nationwide in the United States and internationally to numerous countries including Argentina, Australia, Canada, China, France, Germany, Japan, and the United Kingdom.

Healthcare facilities and users should stop using the affected Quick Reference Guides and follow instructions from Intuitive Surgical regarding the updated documentation.

The recalled product

Product
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
Affected units
2,014

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part number 551993.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →