Recall Z-0918-2012 ยท OAB Low Energy Direct Current Thermal Ablation System
Angiodynamics Worldwide Headquarters
NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
| Date | Jan 27, 2012 (initiated Jan 20, 2012) |
| Status | Terminated |
| Reason | Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance. |
| Root cause | Labeling False and Misleading |
| Action | AngioDynamics sent an Urgent - Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the User's Manual that was supplied with the generator when it was purchased. Instructions include discarding their current manual and troubleshooting guide. A replacement manual will be provided with the Field Safety Notice; the troubleshooting guide will not be replaced. Customers were instructed to complete the Reply Form and fax to AngioDynamics |
| Quantity | 40 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |