Recall Z-3258-2011 ยท OAB Low Energy Direct Current Thermal Ablation System
Angiodynamics, Inc.
ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).
| Date | Sep 23, 2011 (initiated Apr 4, 2011) |
| Status | Terminated |
| Reason | Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture. |
| Root cause | Component design/selection |
| Action | AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice. |
| Quantity | 21 units |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080376 | ONCOBIONIC SYSTEM Oncobionic Incorporated, Apr 2, 2008 |