Events

Recall of Device Recall AEM Disposable Electrodes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encision, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61529
  • Event Risk Class
    Class 2
  • Event Number
    Z-1951-2012
  • Event Initiated Date
    2012-06-15
  • Event Date Posted
    2012-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108356
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    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
    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.

Device

Device Recall AEM Disposable Electrodes
  • Model / Serial
    RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and New Zealand.
  • Product Description
    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. || AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.
  • Manufacturer
    Encision, Inc.

Manufacturer

Encision, Inc.
  • Manufacturer Address
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Manufacturer Parent Company (2017)
    Encision, Inc.
  • Source
    USFDA