Fisher and Paykel Infant Warmer Recall Due to Heater Head Breakage
Fisher and Paykel Healthcare is recalling IW900-Series Infant Warmers and spare parts because a broken nut may allow the heater head to swing and injure infants.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the potential for the heater head to cause a 'serious injury' to a patient, which aligns with the rubric criterion for a score of 4 (Severe) regarding significant injury reports or potential.
Plain-English summary
Fisher & Paykel Healthcare, Ltd. is recalling Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmers and CosyCot and Kit Replacement Head Case Assembly spare parts. The recall involves 661 infant warmers and 180 spare parts in the United States, as well as 2,451 infant warmers and 280 spare parts internationally. The devices are designed to assist with the thermoregulation of infants weighing up to 10kg and are used in labor and delivery rooms and pediatric intensive care units.
The recall is being conducted because the nut that secures the heater head in place may break. This breakage can cause the heater head to become partially detached and swing towards the bassinet. There is a potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
Affected infant warmer model numbers include IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, and IW990XXX. Affected spare parts model numbers are 043041129, 043041130, 043041131, 043042359, and 648040142. Affected serial numbers for infant warmers range from 071116ZZZZZZ to 090810ZZZZZZ, and for spare parts from 071116 to 090810. Healthcare facilities should contact Fisher & Paykel Healthcare, Ltd. for instructions on how to address the defect.
The recalled product
- 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
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
- Category
- Medical Device — Infant Warmer
Distribution
Distributed nationwide across the United States.
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