Health product recall

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