CanadaDa Vinci X Surgical System (model IS4200; USM SN 10234774) and the listed Da Vinci XI Surgical Systems (model IS4000; USM SN 560007, 628656, 579090, 1000606, 670465, 847397, 10045172, 656069, 713959) are affected and can be identified by those model/catalog numbers and USM serial numbers. Intuitive Surgical says certain Universal Surgical Manipulator (USM) screws within the arm sub-assembly may be susceptible to breaking, and customers should arrange for a visit by an Intuitive technician to replace the defective screws.
What's being recalled
Companies: Intuitive Surgical Inc., 1266 Kifer Road, Sunnyvale, California, United States, 94086.
How to identify it
Affected products: Da Vinci X Surgical System IS4200; Lot or serial number: USM SN 10234774; Model or catalogue number: PS4200
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 560007; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 628656; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 579090; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 1000606; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 670465; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 847397; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 10045172; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 656069; Model or catalogue number: IS4000
Affected products: Da Vinci XI Surgical System; Lot or serial number: USM SN 713959; Model or catalogue number: IS4000
The hazard
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 to do
Customer notification. Arrange for visit by Intuitive technician to replace the defective screws in affected units.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)