Recall Z-1428-2013— Intuitive Surgical, Inc.

Name: FDA recall Z-1428-2013
Creator: U.S. Food and Drug Administration
Published: 2011-09-19

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2011-09-19, terminated 2013-05-30. It names one FDA 510(k) clearance: K050369. Product: Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.. Reason: Clarification of existing labeling information and operating procedures..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-09-19
Terminated: 2013-05-30
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K050369 — INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000Intuitive Surgical, Inc.·cleared 2005-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.

Reason for recall

Clarification of existing labeling information and operating procedures.

Data sourced from openFDA. This site is unofficial and independent of the FDA.