Recall Z-1386-2015— Intuitive Surgical, Inc.

Name: FDA recall Z-1386-2015
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 Si Surgical System IS3000, 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 Si Surgical System IS3000, 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.