Events

Recall of PROBP 2400

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WELCH ALLYN CANADA LIMITED.

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
    32603
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-07
  • 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 (microlife corp.) incorrectly installed a component on the printed circuit boards in (2) lots of the probp 2400 during rework in the manufacturing process. as a result of the defective electrical component in the battery charging circuit when the probp 2400 is connected to the external power supply/battery charger a potential over-voltage battery charging condition may occur. this potential defect resides with the device not the battery. the over-voltage condition can result in high nimh battery temperatures that in some cases can reach levels sufficient to cause melting of the plastic (abs) battery door and other adjacent plastic and foam device components.

Device

PROBP 2400
  • Model / Serial
    Model Catalog: 901096 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    PROBP 2400
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED