Events

Recall of PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

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
    91154
  • Event Risk Class
    II
  • 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
    The manufacturer requires that all prisma cfn with the exception of the us market be upgraded to the new software version utilizing the prisma sw r 3.10 upgrade kit.

Device

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
  • Model / Serial
    Model Catalog: (Lot serial: TOUS LES NOS DE SERIE)
  • Product Description
    PRISMA CONTINUOUS FLUID MANAGEMENT SYS.
  • Manufacturer
    GAMBRO INC.

Manufacturer

GAMBRO INC.