AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes u

FDA device recall Z-1951-2012 · posted 2012-07-06 · Terminated

Recall details

Recalling firm

Encision, Inc.

Reason for recall

Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures.

Action taken

Encision sent an Urgent Medical Device Recall letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to lubricate the contact on the instrument cord with a conductive gel (to be supplied by Encision) prior to making the connection of the cord to the instrument. Instructions for applying the gel were attached. This corrective action was temporary; allowing customers to use their inventory of devices and for new product in the short term, until a design correction can resolve the problem. Customers would be contacted by their Encision Sales Representative to review this information for their specific situation and train their staff on its correction. For questions customers should call 303-339-6917 or Customer Service at 800-998-0986. For questions regarding this recall call 303-339-6917.

Root cause

Device Design

Status

Terminated

Product code

GEI

Quantity affected

48 boxes

Distribution

Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.

Date initiated

2012-06-15

Date posted

2012-07-06

Date terminated

2012-08-07

Location

Boulder, CO

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