Events

Recall of Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant Warmers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fisher & Paykel Healthcare Pty 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
    RC-2014-RN-01188-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01188-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Fisher & paykel healthcare is issuing this 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.
  • Action
    Fisher & Paykel Healthcare is providing replacement nut to support the heater head and prevent falling.

Device

Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant Warmers
  • Model / Serial
    Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant WarmersModel Numbers: IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX & IW980XXXSerial Numbers: 071116ZZZZZZ to 090810ZZZZZZSpare Parts:Model Numbers: 043041129, 043041130, 043041131, 043042359, 648040142Lot Numbers: 071116 - 090810 (all spare parts) ARTG number: 100660
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd