Health product recall

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