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Da Vinci S and Da Vinci SI Surgical Systems (2013-07-22)
- Starting date:
- July 22, 2013
- Posting date:
- December 4, 2013
- 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-36955
Recalled products
- Da Vinci S Surgical System - Control for Endoscopic Systems
- Da Vinci SI System - Main
Reason
Voluntary action to provide users with additional information regarding sterile adapter engagement and instrument installation. Although rare, sterile adapter and instrument engagement issues may lead to non-intuitive motion or a sluggish response when controlling instruments. These characteristics are apparent prior to interaction with tissue and thus do not pose a risk to health or safety of patients or users.
Affected products
A. Da Vinci S Surgical System - Control for Endoscopic Systems
Lot or serial number
Not applicable
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
Not applicable
Model or catalog number
- IS3000
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES