Applied Medical Resources Corp: Medical Device Recall in 2015 - (Recall #: Z-2769-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 31, 2015

Date Posted: September 23, 2015

Recall Number: Z-2769-2015

Event ID: 71956

Reason for Recall:

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

Status: Terminated

Product Quantity: 101 units (U.S) and 38 units (International)

Code Information:

Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated