Devices

Device Recall 30 deg, 8mm Endoscope, IS4000

Model / Serial
Model numbers: 470027-34, 470027-40, 470027-41. All lots.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela. .
Product Description
30 deg, 8mm Endoscope, IS4000: || Model numbers: 470027-34, 470027-40, 470027-41. || General and Plastic Surgery: || The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.
Manufacturer
Intuitive Surgical, Inc.
1 Event
- Recall of Device Recall 30 deg, 8mm Endoscope, IS4000

Manufacturer

Intuitive Surgical, Inc.

Manufacturer Address
Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
Manufacturer Parent Company (2017)
Intuitive Surgical Inc
Source
USFDA

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