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Terminated

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

FDA Recall Z-0073-2022 · Posted None

Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeOAB
Date Initiated2020-04-24
Date Terminated2022-09-20
Product Quantity37

Reason for Recall

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

Firm 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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