ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 1280
FDA device recall Z-3258-2011 · posted 2011-09-23 · Terminated
Recall details
- Recalling firm
- Angiodynamics, Inc.
- Reason for recall
- Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.
- Action taken
- AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- OAB
- Quantity affected
- 21 units
- Distribution
- Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,
- Date initiated
- 2011-04-04
- Date posted
- 2011-09-23
- Date terminated
- 2016-01-29
- Location
- Queensbury, NY
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Related 510(k) clearances
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| ONCOBIONIC SYSTEM (K080376) | Oncobionic Incorporated | 2008-04-02 |