PlainRecalls
FDA Devices Moderate Class II Terminated

IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

Reported: July 2, 2014 Initiated: June 11, 2014 #Z-1871-2014

Product Description

IS4000 da Vinci Xi - Endoscope accessory; 0 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

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
19 units
Distribution
Distributed in the states of FL, TX, and NY.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.. Recalled by Intuitive Surgical, Inc.. Units affected: 19 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1871-2014.