Infant Warmer System

• 2 recalls, same reason

  • Terminated Z-2323-2017 FDA Class II ·initiated 5 May 2017
  • Terminated Z-1015-2017 FDA Class II ·initiated 4 Aug 2016

  GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.

• • Terminated Z-1511-2017 FDA Class II ·initiated 18 Nov 2016

  Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

510(k) Number

K963058 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)

  Class II

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  FDA 510(k) K896023 Active Cleared 4 Jan 1990

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