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 instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall involving documentation updates and the removal of a specific tool from instructions, which fits the criteria for moderate severity as it is a precautionary labeling/documentation issue without reported injuries.
Plain-English summary
Intuitive Surgical, Inc. is recalling Quick Reference Guides (QRG) for the da Vinci Standard Surgical System, da Vinci S System, da Vinci Si System, and Si-e. The recall involves Instrument Release Kits (IRK) with part numbers 551979 and 551980. All units distributed prior to June 2014 are affected.
The recall is initiated to update User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK). Specifically, the recall addresses the removal of the Emergency Grip Release Wrench, part number 710142, from the documentation.
The affected products were distributed worldwide, including the United States and numerous international locations. Healthcare facilities and users of the da Vinci Surgical System should verify their documentation and follow instructions from Intuitive Surgical regarding the removal of the Emergency Grip Release Wrench from their Quick Reference Guides.
The recalled product
- Product
- IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
- Manufacturer
- Intuitive Surgical, Inc.
- 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 (2)
- Part number 551979 - da Vinci S
- Si and SI-e Part number 551980 - da Vinci Standard.
Distribution
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.
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