Recall Z-0073-2022 ยท OAB Low Energy Direct Current Thermal Ablation System
Angiodynamics, Inc.
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
| Date | Apr 24, 2020 |
| Status | Terminated |
| Reason | Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On April 24, 2020, the firm distributed recall notifications to their consignees, who were all international (non-US). Customers were advised to stop using the recalled product, remove it from inventory, and segregate in a secure location for return. The firm provided further instructions for the return of the product. |
| Quantity | 37 |
| Distribution | Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150089 | NanoKnife System AngioDynamics, Inc., Jun 18, 2015 |