Device product
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Z-0073-2022
Product summary
- Event
- Event 88679
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37
- Official record key
device-enforcement:Z-0073-2022
Official wording
Reason: Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
Code information: lot 5577754
Distribution pattern: Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.
Derived failure modes
-
Unknown
Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.