Intuitive Surgical da Vinci System User Manual Recall for Sterile Adapter Instructions
Intuitive Surgical is recalling IS3000 user manuals for da Vinci Si and Si-e systems to provide revised instructions for sterile adapter engagement and instrument installation.
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 ensure proper sterile technique, which fits the criteria for moderate severity involving low-risk procedural corrections without reported injuries.
Plain-English summary
Intuitive Surgical, Inc. is recalling the IS3000 User Manual for the Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. The recall involves 1,642 customers who received the manual, identified by model number 550650-05 (P8). The product was distributed worldwide, including the United States and several countries in Europe and Asia.
The recall is being conducted to provide revised instructions for users of the da Vinci S, Si, and Si-e systems. The updated documentation includes additional information regarding sterile adapter engagement and instrument installation. The arm drapes described in the manual are intended to protect equipment from contamination.
Consumers and healthcare facilities should check their inventory for the affected user manual. If the manual is found, users should refer to the revised instructions provided by Intuitive Surgical for proper sterile adapter engagement and instrument installation.
The recalled product
- Product
- IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,642
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)
- Model number 550650-05 (P8)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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Similar recalls
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