Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0210-2015 — 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 unit

U.S. FDA — Device Enforcement · New Zealand · 2014-11-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0210-2015
Date of alert
2014-11-06
Country / jurisdiction
New Zealand
Risk level
Class II
Risk type
recall
Brand
Fisher & Paykel Healthcare, Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
043041129
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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