Recall Monitor
Health Products

Da Vinci X and Da Vinci XI Surigical Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology, Health products - Medical devices - General hospital and personal use
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Da Vinci X Surgical System IS4200USM SN 10234774PS4200
Da Vinci XI Surgical SystemUSM SN 560007IS4000
Da Vinci XI Surgical SystemUSM SN 628656IS4000
Da Vinci XI Surgical SystemUSM SN 579090IS4000
Da Vinci XI Surgical SystemUSM SN 1000606IS4000
Da Vinci XI Surgical SystemUSM SN 670465IS4000
Da Vinci XI Surgical SystemUSM SN 847397IS4000
Da Vinci XI Surgical SystemUSM SN 10045172IS4000
Da Vinci XI Surgical SystemUSM SN 656069IS4000
Da Vinci XI Surgical SystemUSM SN 713959IS4000

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.

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