Ohmeda Medical Giraffe Incubator

• • Terminated Z-2236-2020 FDA Class II ·initiated 28 Apr 2020

  Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

• • Terminated Z-1505-2017 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.

• • Terminated Z-1047-05 FDA Unclassified (pre-2012) ·initiated 25 Apr 2005

  Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.

• • Terminated Z-1064-03 FDA Unclassified (pre-2012) ·initiated 13 Jun 2003 ·on shared 510(k) K020547

  Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K020547 ↗

FDA Product Code

FMZ

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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

  Class II

  FDA 510(k) K072157 Active Cleared 27 Aug 2007

• Ohmeda Medical Omnibed

  Class II

  FDA 510(k) K993407 Active Cleared 5 Jan 2000

• Ohmeda 7900 Anesthesia Ventilator

  Class II

  FDA 510(k) K960964 Active Cleared 27 Sep 1996

• Biliblanket Plus High Output Phototherapy System

  Class II

  FDA 510(k) K993712 Active Cleared 9 Nov 1999

• Cpu-1 Intensive Care Ventilator

  Class II

  FDA 510(k) K871398 Active Cleared 7 May 1987

• Ohmeda 9000 Syringe Pump

  Class II

  FDA 510(k) K896023 Active Cleared 4 Jan 1990

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