Applied Medical Resources Corp recalls Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed

Recalled September 23, 2015 · FDA recall Z-2769-2015 · Applied Medical Resources

Hazard

Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery. · FDA Class II

Units

101 units (U.S) and 38 units (International)

Sold at

Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.

Description

Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.

Product

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(s)

Applied Medical Resources Corp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →