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U.S. Department of Health and Human Services

Class 2 Device Recall Voyant Open Fusion Device

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  Class 2 Device Recall Voyant Open Fusion Device see related information
Date Initiated by Firm July 31, 2015
Date Posted September 15, 2015
Recall Status1 Terminated 3 on November 20, 2015
Recall Number Z-2769-2015
Recall Event ID 71956
510(K)Number K143517  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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.
Code Information Model Number: EB040  Lot Numbers: 1243964, 1243975, 1244125  Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
Recalling Firm/
Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Karen Mitchell
Manufacturer Reason
for Recall
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
FDA Determined
Cause 2
Device Design
Action The firm sent out customer notification letters to International customers the beginning of July 31st, 2015 and domestic customers the week of August 3rd, 2015. The firm's letter requested customers complete the following actions: - check inventory for recalled product - complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if facility is returning or has already used any of the products - Return the confirmation form(s) to Applied Medical by emailing to recall60669166@appliedmedical.com or faxing to (949) 713-8936. - Return affected product and a copy of the confirmation form(s) to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by e-mail at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by e-mail at lcontursi@appliedmedical.com.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = APPLIED MEDICAL RESOURCES