Applied Medical Resources Recalls Voyant Open Fusion Devices
Applied Medical Resources Corp is recalling Voyant Open Fusion Devices due to a potential risk of improper tissue characterization, which may result in nonoptimal power delivery.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (nonoptimal power delivery) where specific injury reports are not stated in the source text, fitting the High severity criteria.
Plain-English summary
Applied Medical Resources Corp is recalling the Voyant Open Fusion Device, models EB040 and EB040+. This medical device is an advanced bipolar instrument designed to be used with the Voyant Electrosurgical Generator to seal vessels up to 5mm or 7mm in diameter and to transect sealed tissue.
The recall was initiated because the device has the potential to improperly characterize tissue within its jaws. This malfunction may result in nonoptimal power delivery during the sealing process.
A total of 101 units were distributed in the United States and 38 units were distributed internationally. In the U.S., the devices were distributed nationwide in Florida, Georgia, and Nevada. Internationally, the devices were distributed in France, the Netherlands, Spain, and the United Kingdom. Affected lot numbers for model EB040 are 1243964, 1243975, and 1244125. Affected lot numbers for model EB040+ are 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, and 1249264.
The recalled product
- 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…
- Manufacturer
- Applied Medical Resources Corp
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Model Number: EB040 Lot Numbers: 1243964
- 1243975
- 1244125 Model Number: EB040+ Lot Numbers: 1245512
- 1245513
- 1246241
- 1246508
- 1247079
- 1247566
- 1248102
- 1249264
Distribution
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