Events

Recall of AERONEB PRO-X - CONTROLLER KIT

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

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
    25407
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-05
  • 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
    Aerogen has received a small number of complaints in relation to the mains power adapter manufactured by friwo gmbh and used in the aeroneb solo and pro nebuliser systems. the complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use. however it cannot be ruled out that the adapter may fail during use. if the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user. therefore there is a potential risk of electric shock if the cover falls off during use with mains power turned on and the user makes contact with specific recessed components inside the adapter housing.

Device

AERONEB PRO-X - CONTROLLER KIT
  • Model / Serial
    Model Catalog: AG-PX1000-US (Lot serial: N/A); Model Catalog: AG-AP1040-US (Lot serial: N/A)
  • Product Description
    AERONEB PRO X CONTROLLER
  • Manufacturer
    AEROGEN LTD

Manufacturer

AEROGEN LTD
  • Manufacturer Address
    DANGAN
  • Manufacturer Parent Company (2017)
    Aerogen Ltd.
  • Source
    HC