Recall Z-2769-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Applied Medical Resources Corp
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 b
| Date | Sep 15, 2015 (initiated Jul 31, 2015) |
| Status | Terminated |
| Reason | Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143517 | Voyant Open Sealer-Divider Device Applied Medical Resources, Mar 27, 2015 |