PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 23, 2015 Initiated: July 31, 2015 #Z-2769-2015

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.

Reason for Recall

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

Details

Units Affected
101 units (U.S) and 38 units (International)
Distribution
Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
Location
Rancho Santa Margarita, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Applied Medical Resources Corp. Units affected: 101 units (U.S) and 38 units (International).
Why was this product recalled? ▼
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2015. Severity: Moderate. Recall number: Z-2769-2015.

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