Events

Recall of INTEGRA ALPHA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAMBRO 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
    108999
  • Event Risk Class
    I
  • Event Initiated Date
    2002-04-02
  • 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
    Under particular circumstances overheating and subsequent failure of the optotriac 25 amperes.

Device

INTEGRA ALPHA
  • Model / Serial
    Model Catalog: (Lot serial: S/N 750100 TO S/N 759328); Model Catalog: (Lot serial: C/N 752804); Model Catalog: (Lot serial: DEV LIC #12711); Model Catalog: (Lot serial: ESTAB LIC # 752804); Model Catalog: (Lot serial: QSG 004/02-EP); Model Catalog: (Lot serial: S/N 760100 TO S/N 760871)
  • Product Description
    integra alpha
  • Manufacturer
    GAMBRO INC.

Manufacturer

GAMBRO INC.