Servo-Control Wall-Mount Infant Warmer(IW980)/Manual-Control Wall-Mount Infant Warmer(IW990)

• • 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.

510(k) Number

K971461 ↗

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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