Recall Z-1384-2015— Intuitive Surgical, Inc.

Name: FDA recall Z-1384-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-16

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2015-03-16, terminated 2015-12-03. It names one FDA 510(k) clearance: K050322. Product: da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.. Reason: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-16
Terminated: 2015-12-03
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K050322 — MICROTEK EQUIPMENT DRAPESMicrotek Medical, Inc.·cleared 2005-05-17

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

da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

Reason for recall

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

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