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Da Vinci S Surgical System, Da Vinci SI System and Da Vinci Surgical System (2014-06-03)
- Starting date:
- June 3, 2014
- Posting date:
- July 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40255
Recalled Products
A) Da Vinci S Surgical System - Control for Endoscopic Instruments
B) Da Vinci SI System -Main
C) Da Vinci Surgical System (Model IS1200)
Reason
Labelling updates to distributed user manuals, instructions for use, quick reference guides, and instrument release kit for use with Da Vinci surgical systems, and instruments and accessories. Updates have been implemented to incorporate user feedback not previously addressed.
Affected products
A) Da Vinci S Surgical System - Control for Endoscopic Instruments
Lot or serial number
All lots contact manufacturer.
Model or catalog number
IS2000
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES
B) Da Vinci SI System -Main
Lot or serial number
All lots contact manufacturer.
Model or catalog number
IS3000
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES
C) Da Vinci Surgical System (Model IS1200)
Lot or serial number
All lots contact manufacturer.
Model or catalog number
IS1200
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES