Food, drugs, devices › Applied Medical Resources Corp
Device recall: Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for
FDA enforcement event 71956 is a device recall by Applied Medical Resources Corp of Rancho Santa Margarita, CA, initiated 31 Jul 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 20 Nov 2015. Initiation: voluntary: firm initiated. Applied Medical Resources Corp has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Applied Medical Resources Corp, Rancho Santa Margarita, CA.
Reason for recall
"Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery."
Distribution
"Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2769-2015 | 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… | 101 units (U.S) and 38 units (International) | Class II | Terminated | 23 Sep 2015 |
Context
Other enforcement events for Applied Medical Resources Corp
All 15 events for Applied Medical Resources Corp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Nov 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.