Events

Recall of BD PHOENIX SYSTEM - AP (SAMPLE PREP INSTRUMENT)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA 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
    62920
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-02
  • 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
    Bd has recently confirmed a manufacturing issue with the motor that drives movement of the robot arm. should this occur the instrument will indicate an e20 error and stop functioning. while there is no loss of patient sample the samples would need to be manually processed. bd a r?cemment confirm? un probl?me de fabrication avec le moteur qui anime le mouvement du bras du robot. si ce probl?me se manifeste l'instrument indiquera un code d'erreur e20 et cessera de fonctionner. tandis qu'il n'y a pas de perte d'?chantillons provenant des patients les ?chantillons devront ?tre trait?s manuellement.

Device

BD PHOENIX SYSTEM - AP (SAMPLE PREP INSTRUMENT)

Manufacturer

BECTON DICKINSON CANADA INC.