Devices

Device Recall Voyant Open Fusion Device

Model / Serial
Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
Product Description
Voyant Open Fusion Device || Models: EB040 and EB040+ || Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.
Manufacturer
Applied Medical Resources Corp
1 Event
- Recall of Device Recall Voyant Open Fusion Device

Manufacturer

Applied Medical Resources Corp

Manufacturer Address
Applied Medical Resources Corp, 22872 Avenida Empresa, Rancho Santa Margarita CA 92688-2650
Manufacturer Parent Company (2017)
Applied Medical Corporation
Source
USFDA

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