Public recall detail

Da Vinci X and Da Vinci XI Surigical Systems

2026-05-13

medium
Gastroenterology and urology - General hospital and personal use Performance
Quick summary

Quick summary: Da Vinci X and Da Vinci XI Surigical Systems. Reason: Performance. Category: Gastroenterology and urology - General hospital and personal use. Date: 2026-05-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Da Vinci X and Da Vinci XI Surigical Systems. Reason: Performance. Category: Gastroenterology and urology - General hospital and personal use. Date: 2026-05-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandIntuitive Surgical Inc.
ProductDa Vinci X and Da Vinci XI Surigical Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82065

Affected products

ProductDa Vinci X Surgical System IS4200
LotUSM SN 10234774
ModelPS4200
Serial numberUSM SN 10234774
DescriptionDa Vinci X Surgical System IS4200
ProductDa Vinci XI Surgical System
LotUSM SN 560007
ModelIS4000
Serial numberUSM SN 560007
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 628656
ModelIS4000
Serial numberUSM SN 628656
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 579090
ModelIS4000
Serial numberUSM SN 579090
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 1000606
ModelIS4000
Serial numberUSM SN 1000606
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 670465
ModelIS4000
Serial numberUSM SN 670465
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 847397
ModelIS4000
Serial numberUSM SN 847397
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 10045172
ModelIS4000
Serial numberUSM SN 10045172
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 656069
ModelIS4000
Serial numberUSM SN 656069
DescriptionDa Vinci XI Surgical System
ProductDa Vinci XI Surgical System
LotUSM SN 713959
ModelIS4000
Serial numberUSM SN 713959
DescriptionDa Vinci XI Surgical System

Issue

Intuitive is initiating a voluntary correction involving the Universal Surgical Manipulator (USM) on the Da Vinci X and XI systems as certain USM's may contain screws located within the arm sub-assembly that may be susceptible to breaking.

What you should do

  • Customer notification. Arrange for visit by Intuitive technician to replace the defective screws in affected units.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - General hospital and personal use
CompaniesIntuitive Surgical Inc. 1266 Kifer Road, Sunnyvale, California, United States, 94086
Recall date2026-04-07
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82065
Background{}
CompaniesIntuitive Surgical Inc. 1266 Kifer Road, Sunnyvale, California, United States, 94086
AudiencesHealthcare
Source updated2026-05-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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