Recall Z-0359-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Corporation
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
| Date | Dec 1, 2015 (initiated Nov 5, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | On November 4, 2015, ConMed Corporation distributed Urgent Device Recall Notification letters dated November 5, 2015 to their customers via overnight courier service. Customers should stop the use of these devices immediately. The recall notice recipient should contact all organizations within their facility and any other facilities that may have received the affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Customers with questions can call Patricia Cotter, ConMed Recall Coordinator 315-624-3237 (8AM - 5PM EST, Monday thro |
| Quantity | 9 devices |
| Distribution | Distributed in the states of CA, and TX and in the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140459 | ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM Conmed Corporation, Jul 11, 2014 |