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Recall Observatory FDA recall evidence

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

April 24, 2020

Class II

Product summary

Firm
Angiodynamics, Inc.
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

    reason.no_named_rule · v1.0.0

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