Intuitive Surgical Recalls da Vinci System Manuals Due to Wrench Removal
Intuitive Surgical is recalling da Vinci Surgical System manuals and guides 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The specific action is the removal of a tool reference from documentation, which is a precautionary labeling update.
Plain-English summary
Intuitive Surgical, Inc. is recalling the System Manual, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for the da Vinci Standard, S, and Si Surgical Systems. The recall involves the removal of the Emergency Grip Release Wrench, part number 710142, from these documents.
The affected documents were distributed worldwide prior to June 2014. This includes distribution in the United States and internationally to numerous countries including Argentina, Australia, Austria, Belgium, Brazil, and others. The specific part numbers for the manuals are 550120 for the standard system, 550516 for the S system, and 550650 for the Si system.
This action is classified as an FDA Class II recall. Users should refer to the updated documentation provided by the manufacturer to ensure correct usage of the surgical system instruments and accessories.
The recalled product
- Product
- System Manual 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 (2)
- Part numbers 550120 for standard
- 550516 for S system and 550650 for Si System.
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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