CLASS II Device recall · Reported 19 Nov 2014 · FDA Enforcement Report

(FPH) IW900-Series Infant Warmer Fisher and Paykel recalled

Fisher & Paykel Healthcare is recalling (FPH) IW900-Series Infant Warmer Fisher and Paykel, distributed nationwide in the US. The recall was initiated on 6 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ Spare Parts: 071116 - 090810

Quantity recalledNationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0210-2015
FDA event ID: 69668
Recalling firm: Fisher & Paykel Healthcare, Auckland
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2014
FDA classified: 13 Nov 2014
Reported: 19 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

6 Nov 2014	Recall initiated by company
13 Nov 2014	Classified by FDA	+7 days
19 Nov 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Affected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ Spare Parts: 071116 - 090810

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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