Health product recall

Da Vinci X and Da Vinci XI Surigical Systems

Last updated

Summary

Product
Da Vinci X and Da Vinci XI Surigical Systems
Issue
Medical devices - Performance
What to do

Customer notification. Arrange for visit by Intuitive technician to replace the defective screws in affected units.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Da Vinci X Surgical System IS4200

USM SN 10234774

PS4200

Da Vinci XI Surgical System

USM SN 560007

IS4000

Da Vinci XI Surgical System

USM SN 628656

IS4000

Da Vinci XI Surgical System

USM SN 579090

IS4000

Da Vinci XI Surgical System

USM SN 1000606

IS4000

Da Vinci XI Surgical System

USM SN 670465

IS4000

Da Vinci XI Surgical System

USM SN 847397

IS4000

Da Vinci XI Surgical System

USM SN 10045172

IS4000

Da Vinci XI Surgical System

USM SN 656069

IS4000

Da Vinci XI Surgical System

USM SN 713959

IS4000

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General hospital and personal use
Companies
Intuitive Surgical Inc.
1266 Kifer Road, Sunnyvale, California, United States, 94086
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82065

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe