Recall Z-2106-2012— Intuitive Surgical, Inc.

Name: FDA recall Z-2106-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-13

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2012-07-13, terminated 2013-06-12. It names one FDA 510(k) clearance: K050369. Product: ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.. Reason: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Terminated: 2013-06-12
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

ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

Reason for recall

Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

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