FDAFDA · Food and drugs·Recall number Z-1870-2014
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Published July 2, 2014 · Recall initiated: June 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Distributed in the states of FL, TX, and NY.
- Lot
- 470027-20
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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