IS4000 (Erbe Footswitch) (2019-02-26)
- Starting date:
- February 26, 2019
- Posting date:
- March 15, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69294
Affected Products
IS4000 (Erbe Footswitch)
Reason
The user manual for the Erbe Footswitch contained within the Vision Cart was not provided when the system was installed. Therefore, ISI will be sending an Erbe Footswitch user manual to each da Vinci Xi customer in order to correct this issue.
Affected products
IS4000 (Erbe Footswitch)
Lot or serial number
- System Name SK1069
- System Name SK1134
- System Name SK1421
Model or catalog number
IS4000
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
California
UNITED STATES