Da Vinci X and Da Vinci XI Surigical Systems
Brand(s)
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
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