Events

Recall of INFANT RADIANT WARMERS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FISHER AND PAYKEL HEALTHCARE 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
    19328
  • Event Risk Class
    I
  • Event Initiated Date
    2014-11-03
  • 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
    Fisher & paykel healthcare is issuing this voluntary recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case. however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.

Device

INFANT RADIANT WARMERS
  • Model / Serial
    Model Catalog: IW952 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW980 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW920 (Lot serial: 071208002349 TO 090717000930); Model Catalog: IW910 (Lot serial: 071208002349 TO 090717000930); Model Catalog: 648040142 (Lot serial: 071116 TO 090810); Model Catalog: 043042359 (Lot serial: 071116 TO 090810); Model Catalog: 043041130 (Lot serial: 071116 TO 090810); Model Catalog: IW954 (Lot serial: 071116 TO 090810); Model Catalog: IW953 (Lot serial: 071116 TO 090810); Model Catalog: IW951 (Lot serial: 071116 TO 090810); Model Catalog: IW990 (Lot serial: 071116 TO 090810); Model Catalog: IW934 (Lot serial: 071116 TO 090810); Model Catalog: IW933 (Lot serial: 071116 TO 090810); Model Catalog: IW932 (Lot serial: 071116 TO 090810); Model Catalog: IW931 (Lot serial: 071116 TO 090810); Model Catalog: IW952 (Lot serial: 071116 TO 090810); Model Catalog: IW980 (Lot serial: 071116 TO 090810); Model Catalog: IW920 (Lot serial: 071116 TO 090810); Model Cat
  • Product Description
    INFANT RADIANT WARMERS
  • Manufacturer
    FISHER AND PAYKEL HEALTHCARE LTD.

Manufacturer

FISHER AND PAYKEL HEALTHCARE LTD.