Device Recall Fisher and Paykel Healthcare CosyCot and Kit Replacement Head

  • Modèle / numéro de série
    Affected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ  Spare Parts: 071116 - 090810
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico. Morocco, New Zealand, Nigeria, Northern Ireland, Norway, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, singapore, Slovenia, South Africa, Spain, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, and West Bank.
  • Description du dispositif
    Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer || Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly || It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. || Infant Warmers Model Number (REF) || IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX || Spare Parts Model Number (REF) || 043041129, 043041130, 043041131, 043042359, 648040142
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Fisher & Paykel Healthcare, Ltd., 15 Maurice Paykel Place, East Tamaki, Auckland New Zealand
  • Source
    USFDA