Events

Recall of AQUARIUS SYSTEM - AQUARIUS PLATINUM SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

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
    22296
  • Event Risk Class
    III
  • Event Initiated Date
    2011-12-02
  • 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
    Baxter received reports of 8 cases of broken/damaged wheels on the aquarius. the damage to the wheels occurred during the moving of the device. the damaged wheel may result in loss of stability of the device. in the worst case the device can fall over and potentially harm a person.

Device

AQUARIUS SYSTEM - AQUARIUS PLATINUM SOFTWARE
  • Model / Serial
    Model Catalog: GEF08200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: GEF09700 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ACUTE RENAL DIALYSIS MACHINE AQUARIUS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION