Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1386-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-03-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1386-2015
Date of alert
2015-03-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intuitive Surgical, Inc.
Product category
device
Product type
Devices
Reported risk: Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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