Infant Radiant Warmer - Models IW910 and IW920

• • Terminated Z-0210-2015 FDA Class II ·initiated 6 Nov 2014

  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.

• • Terminated Z-0485-2007 FDA Unclassified (pre-2012) ·initiated 9 Oct 2006

  This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result.

510(k) Number

K970432 ↗

FDA Product Code

FMT

FDA applicant

Fisher & Paykel Electronics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K953949 Active Cleared 16 Oct 1995

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