Reported Sep 23, 2015 · Terminated
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for…
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
- Voyant Open Fusion Device ModelsEB040 and EB040+
- Product UsageThe 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
- Lot codes and dates
- Model NumberEB040
- Lot Numbers
124396412439751244125
- Model NumberEB040+
- Lot Numbers
12455121245513124624112465081247079124756612481021249264
- Amount recalled
- 101 units (U.S) and 38 units (International)
Where it was sold
Why it was recalled
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
This product could cause temporary or reversible health problems — stop using it.
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