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Sterile adapter for IS3000 model (2013-04-19)
- Starting date:
- April 19, 2013
- Posting date:
- March 18, 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-38233
Recalled Products
Sterile adapter for IS3000 model
Reason
Intuitive Surgical System uses a Sterile Adapter as the interface between the (Sterile) instrument and the (Non-sterile) system. For the IS2000 and IS3000 system models, the Sterile Adapter is integrated into the instrument arm drape. Intuitive Surgical is implementing a voluntary action to provide users of the Da Vinci S, SI and SI-E systems with additional information regarding sterile adapter engagement and instrument installation. A quick reference guide has been developed so that all customers can consistently achieve reliable instrument performance.
Affected products
Sterile adapter for IS3000 model
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
IS2000
IS3000
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES