Intuitive Surgical Recalls Vessel Sealer Addendum for da Vinci Systems
Intuitive Surgical is recalling Vessel Sealer Addendum software for da Vinci surgical systems to update user manuals and remove 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 documentation updates and the removal of a specific tool, which aligns with the rubric for moderate severity involving labeling or documentation issues without reported injuries.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Vessel Sealer Addendum for the da Vinci Standard Surgical System, da Vinci S System, and da Vinci Si System. The recall involves multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) used with the da Vinci Surgical System, instruments, and accessories.
The recall is being conducted to implement these documentation updates and to remove the Emergency Grip Release Wrench, part number 710142. The affected product is identified by part number 551027. All units distributed prior to June 2014 are included in this recall.
The product was distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare facilities and users of the da Vinci Surgical System should contact Intuitive Surgical for instructions on how to update their documentation and remove the specified wrench.
The recalled product
- Product
- Vessel Sealer Addendum 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.
- Category
- Medical Device — Surgical Robot
- 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 551027
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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