Fisher & Paykel Healthcare, Ltd.: 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

Recall number

Z-0210-2015

Recalling firm

Fisher & Paykel Healthcare, Ltd.

Product

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

Status

Terminated

Initiated

2014-11-06

Posted

2014-11-13

Terminated

2015-04-27

Reason

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.

Root cause

Manufacturing material removal

Action

Fisher & Paykel Healthcare sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Step 1: Identify any affected Infant Warmers in your inventory by checking the REF and SERIAL number on the device label (see examples in Figures 1 and 2). Step 2: Identify any affected spare parts in your inventory by checking the REF and LOT number on the parts (see example in Figure 3). Step 3: Check your Infant Warmer service records to determine if affected spare parts were installed on any other Infant Warmers. If you are unable to identify specific Infant Warmers that may have had affected spare parts installed, then please contact FPH at the contact details below. Step 4: Replacement of Affected Nut. - Remove the affected Infant Warmer from use. - Switch the warmer off and disconnect it from the mains power supply. - Support the heater head during disassembly to prevent it from falling. - Follow Steps A to F in Figure 4 below to replace the nut. - Ensure the pivot washer remains in place when installing the new nut. - Ensure that the heater head is secure, can rotate smoothly, and the detent locates the head in the central position. - Reconnect the mains power supply, switch the warmer on, and ensure there are no error codes or alarms before returning to use. Step 5: Complete the Urgent Medical Device Recall Response Form and return it to your FPH Representative

Quantity

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

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.

Lot, serial or model codes

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

510(k) numbers

["K970432","K971461"]

PMA numbers

not on file

Product code

FMT

Firm FEI

3002806988

Firm city

Auckland

Firm state

East Tamaki

Firm country

New Zealand

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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