Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS GmbH, Germany. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
FDA Recall Z-1678-2012 · Posted 2012-05-29
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Recalling FirmConMed Electrosurgery
Recall StatusTerminated
Product CodeGEI
Date Initiated2012-05-07
Date Terminated2012-06-19
Product Quantity122 units
Reason for Recall
An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery.
Firm Action
ConMed Electrosurgery sent an "URGENT: MEDICAL DEVICE" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to complete and return a Business Reply Form to the firm via fax to 303-699-9854.
Root Cause
Equipment maintenance
Distribution Pattern
Nationwide Distribution and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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