Recall Z-1678-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
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.
| Date | May 29, 2012 (initiated May 7, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Equipment maintenance |
| 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. |
| Quantity | 122 units |
| Distribution | Nationwide Distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101534 | CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM Conmedcorp, Nov 24, 2010 |