Intuitive Surgical, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1109-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.

Product Classification:

Class II

Date Initiated: March 15, 2013

Date Posted: April 24, 2013

Recall Number: Z-1109-2013

Event ID: 64755

Reason for Recall:

Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.

Status: Terminated

Product Quantity: 1642 customers

Code Information:

Model number 550516-05

Distribution Pattern:

Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated