Events

Recall of POWER PROCESSOR AUTOMATION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    17593
  • Event Risk Class
    III
  • Event Initiated Date
    2015-10-05
  • 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
    Beckman coulter has identified that the centrifuge module on the power processor sample processing system exceeds the published acoustic noise specification of 74 decibels. beckman coulter iimplemented a new centrifuge motor on the power processor which included an additional cooling fan mounted directly on the motor shaft that spins when the centrifuge motor runs during centrifugation. as a result centrifuges with the new motor have two cooling fans that are positioned very close to each other and spin in opposite directions causing air turbulence and acoustic noise.

Device

POWER PROCESSOR AUTOMATION SYSTEM
  • Model / Serial
    Model Catalog: A11036 (Lot serial: 90HP1301002)
  • Product Description
    POWER PROCESSOR SAMPLE PROCESSING SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.