Intuitive Surgical Recalls da Vinci Manuals Due to Wrench Removal
Intuitive Surgical is recalling da Vinci Surgical System manuals to remove the Emergency Grip Release Wrench from the documentation.
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 corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling Single Site US Manuals and Single Site OUS Manuals 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 the user manuals, instructions for use, quick reference guides, and instrument release kits.
The affected products include part number 551184 (US Manual) and part number 550965 (OUS manuals). These manuals were distributed worldwide, including in the United States and numerous international locations, prior to June 2014.
This action is a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences. Users should refer to the updated documentation provided by the manufacturer to ensure correct usage of the surgical system.
The recalled product
- Product
- Single Site US Manuals and Single Site OUS Manuals 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 number 551184 - US Manual
- Part number 550965 - OUs manuals.
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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