Intuitive Surgical da Vinci Si Surgeon Console Labeling Clarification
Intuitive Surgical is clarifying labeling and operating procedures for the da Vinci Si Surgeon Console to ensure accurate control of endoscopic instruments.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling clarification without reported injuries or illnesses, fitting the criteria for a Low severity recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Si Surgeon Console, model number 314850, versions 1-6. The device is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
The recall is initiated to clarify existing labeling information and operating procedures. The source text does not report any specific injuries, illnesses, or malfunctions associated with this clarification.
The affected units were distributed worldwide, including the USA and various international markets such as Argentina, Australia, Canada, and China. Users should refer to the updated labeling and operating procedures provided by the manufacturer.
The recalled product
- Product
- da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Robot
- Hazard
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)
- Model number: 314850
- versions 1-6
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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