da Vinci S/Si Surgical System (2021-06-09)
- Starting date:
- June 9, 2021
- Posting date:
- June 30, 2021
- 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-75931
Last updated: 2021-06-30
Affected Products
A. VISION SYSTEM CART
B. DA VINCI SI SYSTEM - MAIN
Reason
The number of uses and number of reprocessing cycles for the da Vinci S/Si Harmonic ACE Reusable Instrument Housings (5mm PN: 420274-XX /8mm PN: 420275-XX) are incorrectly listed as "N/A" in the S/SI reprocessing IFU appendices. Correct information for S/SI Harmonic Ace Reusable Instrument Housing is as listed: Correct Number of Uses is 20 and Correct Number of Reprocessing cycles is 25.
Affected products
A. VISION SYSTEM CART
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IS2000
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
California
UNITED STATES
B. DA VINCI SI SYSTEM - MAIN
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IS3000
Companies
- Manufacturer
-
Intuitive Surgical Inc.
1266 Kifer Road, Building 100, 101, 102, 103
Sunnyvale
94086
California
UNITED STATES