Recall Z-1870-2014— Intuitive Surgical, Inc.

Name: FDA recall Z-1870-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-11

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2014-06-11, terminated 2014-07-02. It names one FDA 510(k) clearance: K131861. Product: IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.. Reason: In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue.

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Terminated: 2014-07-02
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

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

IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.

Reason for recall

In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

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