NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable

FDA device recall Z-0918-2012 · posted 2012-01-27 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance.

Action taken

AngioDynamics sent an Urgent - Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the User's Manual that was supplied with the generator when it was purchased. Instructions include discarding their current manual and troubleshooting guide. A replacement manual will be provided with the Field Safety Notice; the troubleshooting guide will not be replaced. Customers were instructed to complete the Reply Form and fax to AngioDynamics at 518-798-1360. If customers further distributed the affected product, they should inform those accounts of the field correction. Angiodynamics will also disable the AZE feature during a schedule service visit. For questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

OAB

Quantity affected

40 units

Distribution

Nationwide Distribution

Date initiated

2012-01-20

Date posted

2012-01-27

Date terminated

2016-02-10

Location

Latham, NY

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