Intuitive Surgical Recalls da Vinci Vision Troubleshooting Guides
Intuitive Surgical is recalling Vision Troubleshooting Guides for the da Vinci Surgical System to remove references to the Emergency Grip Release Wrench.
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: The recall is classified as FDA Class II and involves a documentation update to remove a specific tool reference, which aligns with the rubric for moderate severity issues involving labeling or documentation corrections without reported injuries.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Vision Troubleshooting Guide for the da Vinci Standard Surgical System, da Vinci S System, and da Vinci Si System. The recall involves all copies of the guide distributed prior to June 2014, identified by part number 550866.
The recall is being conducted to update user manuals, instructions for use, quick reference guides, and instrument release kits. 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 in the United States and numerous international locations. Users of the da Vinci Surgical System should check their documentation for the presence of the Emergency Grip Release Wrench and follow instructions from Intuitive Surgical regarding the updated materials.
The recalled product
- Product
- Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- 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 550866
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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