Events

Recall of CELERITY SYSTEM - ECG CABLE PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ANGIODYNAMICS 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
    46691
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-12
  • 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
    Angiodynamics is recalling product that has the potential to contain an ecg clip cable that was not properly manufactured. the affected product is not soldered per specification and may result in the device not properly conducting the ecg signal. angiodynamics began distributing product affected by this recall on february 19 2015.

Device

CELERITY SYSTEM - ECG CABLE PACK
  • Model / Serial
    Model Catalog: H787471431 (Lot serial: MBVT250D)
  • Product Description
    CELERITY-ECG CABLE ACCESSORY PACK
  • Manufacturer
    ANGIODYNAMICS INC.

Manufacturer

ANGIODYNAMICS INC.
  • Manufacturer Address
    MARLBOROUGH
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    HC