Reported Dec 9, 2015 · Terminated
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and…
ConMed Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConMed Corporation · 525 French Rd · Utica, NY · 13502-5945
Is this the product you have?
- Altrus Thermal Tissue Fusion Energy Sources
- Catalog Numbers1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source
- Lot codes and dates
- Serial Numbers
1) 15090103 & 151500051515000615150007151500081515000915150010151500111515001215130004152500131525001415250015152500161525001715300018 & 153000202) 1505000115300005 & 15300006
- Serial Numbers
- Amount recalled
- 9 devices
Where it was sold
Why it was recalled
Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.
This product could cause temporary or reversible health problems — stop using it.
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