Health product recall

Da Vinci Surgical Systems

Last updated

Summary

Product
Da Vinci Surgical Systems
Issue
Medical devices - Performance issue
What to do

CAPA 552131 started to address issue. Customers provided with further instructions in response. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Da Vinci X Surgical System Is4200

Contact manufacturer.

PS4200

Da Vinci Xi Surgical System Is4000

Contact manufacturer

IS4000

Issue

An increase in reports in which a loose instrument carriage is observed on the universal side manipulator (usm) or the instrument arm of the Da Vinci X and Xi systems.  The loose instrument carriage is an outcome of a linear rail component being out of specification. The loose instrument carriage makes it possible for the carriage to wobble along the linear rail in response to force applied to the carriage or to the shaft of an installed instrument.

Recall start date: February 23, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Health products - Medical devices - General hospital and personal use
Companies

Intuitive Surgical Inc.

1266 Kifer Road, Sunnyvale, California, United States, 94086

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73120

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