Events

Recall of LIFEMATE HEMOFILTRATION SYSTEM - CYCLER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NXSTAGE MEDICAL 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
    29018
  • Event Risk Class
    II
  • Event Initiated Date
    2001-01-27
  • 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
    During review of test data from the mandatory report involving a problem clearing alarms and resetting the devicea software problem was found.The problem caused the processor to overide certain safety alarms.

Device

LIFEMATE HEMOFILTRATION SYSTEM - CYCLER
  • Model / Serial
    Model Catalog: (Lot serial: DEV LIC # 21999 25193); Model Catalog: (Lot serial: CARTIDGE LOT FG-001114-02); Model Catalog: (Lot serial: CAT #'S P4U / UCP0001); Model Catalog: (Lot serial: CYCLER S/N 5007)
  • Product Description
    lifemeate hemofiltration system
  • Manufacturer
    NXSTAGE MEDICAL INC.

Manufacturer

NXSTAGE MEDICAL INC.
  • Manufacturer Address
    LAWRENCE
  • Source
    HC