Recalls / —
—#189276
Product
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
- FDA product code
- OAB — Low Energy Direct Current Thermal Ablation System
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K150089
- Affected lot / code info
- lot 5577754
Why it was recalled
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 (FDA determination)
Software Manufacturing/Software Deployment
Action the firm took
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.
Recalling firm
- Firm
- Angiodynamics, Inc.
- Address
- 603 Queensbury Ave, Queensbury, New York 12804-7619
Distribution
- Distribution pattern
- Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.
Timeline
- Recall initiated
- 2020-04-24
- Terminated
- 2022-09-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.