Events

Recall of AEM MONITORS

According to Health Canada (via FOI), this recall involved a device in Canada 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
    86875
  • Event Risk Class
    II
  • Event Initiated Date
    2003-11-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Use of the nc version of aem monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes. dk.

Device

AEM MONITORS
  • Model / Serial
    Model Catalog: EM2M NC (Lot serial: cat#EM2M NC P2L1221); Model Catalog: EM2+A NC (Lot serial: ALL SERIAL #'S); Model Catalog: EM2M NC (Lot serial: cat#EM2M NC S/N#P2F1080); Model Catalog: EM2+A NC (Lot serial: cat#EM2M NC P2L1221); Model Catalog: EM2M NC (Lot serial: ALL SERIAL #'S); Model Catalog: EM2+A NC (Lot serial: cat#EM2M NC S/N#P2F1080)
  • Product Description
    AEM Monitor (NC Model)
  • Manufacturer
    ENCISION INC.

Manufacturer

ENCISION INC.
  • Manufacturer Address
    BOULDER
  • Source
    HC