Intuitive Surgical Recalls da Vinci TORS User Manual Addendum
Intuitive Surgical is recalling 1,374 user manual addenda for the da Vinci Surgical System to remove an indication and amend warnings for Transoral Surgery.
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 involves a documentation update to correct indications and warnings without reported injuries or illnesses, fitting the criteria for minor labeling or documentation issues.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,374 copies of the User Manual addendum for Transoral Surgery (TORS) for the da Vinci Surgical System IS 1200, IS 2000, and IS 3000. The affected product is identified by model number 552002-01 and was distributed only within the United States.
The recall was initiated to remove one indication for use and to amend warnings to emphasize restrictions for use. The original manual provided information to update the Indications for Use and Representative uses sections and add warnings for Transoral Otolaryngology Surgery.
Healthcare facilities and users of the da Vinci Surgical System should stop using the affected manual addendum and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings…
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 1,374
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 552002-01
Distribution
Distribution scope not specified by the agency.
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