Events

Recall of BIPAP A40 CANADA CORE PACKAGE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESPIRONICS 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
    134686
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-03
  • 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
    Philips respironics has identified an issue where a non-conforming part (side panel) was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module. the issue results in the inability to connect the bipap a40 device to the detachable battery module during setup before putting the ventilator into operation on a user.

Device

BIPAP A40 CANADA CORE PACKAGE
  • Model / Serial
    Model Catalog: 1111174 (Lot serial: N/A); Model Catalog: 1111173 (Lot serial: N/A)
  • Product Description
    BIPAP A40 CANADA
  • Manufacturer
    RESPIRONICS INC.

Manufacturer

RESPIRONICS INC.
  • Manufacturer Address
    MURRYSVILLE
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC