FDA-Device2021-10-13Class II

AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

Angiodynamics, Inc.
Hazard

Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.

Sold states
Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.
Affected count
37
Manufactured in
603 Queensbury Ave, Queensbury, NY, United States
Products
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0073-2022

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