ConMed Recalls Altrus Thermal Tissue Fusion Energy Sources
ConMed is recalling nine Altrus Thermal Tissue Fusion Energy Sources due to a miscalibration issue that may cause false alarms and stop heating cycles.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect causing false alarms and stopped heating cycles without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ConMed Corporation is recalling nine Altrus Thermal Tissue Fusion Energy Sources, catalog numbers 60-9500-120 and 60-9500-INT. These devices are used for thermal ligation and cutting.
The recall is due to a miscalibration of the energy source monitoring function. This defect may cause the device to incorrectly sense the handpiece temperature as higher than the actual temperature. As a result, some devices may generate a "Check Seal" message with an audible alarm and stop the heating cycle.
The affected devices were distributed in California, Texas, and Mexico. Specific serial numbers are listed in the recall documentation. Users should contact ConMed Corporation for further instructions on the recall.
The recalled product
- Product
- Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
- Manufacturer
- ConMed Corporation
- Hazard
- Affected units
- 9
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 (17)
- Serial Numbers: 1) 15090103 & 15150005
- 15150006
- 15150007
- 15150008
- 15150009
- 15150010
- 15150011
- 15150012
- 15130004
- 15250013
- 15250014
- 15250015
- 15250016
- 15250017
- 15300018 & 15300020
- 2) 15050001
- 15300005 & 15300006
Distribution
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