Recall Z-1505-2017— Ohmeda Medical

Name: FDA recall Z-1505-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-18

Class II · Terminated

Class II FDA medical device recall by Ohmeda Medical, initiated 2016-11-18, terminated 2018-07-13. It names one FDA 510(k) clearance: K020547. Product: Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).. Reason: 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..

Recalling firm: Ohmeda Medical
Classification: Class II
Status: Terminated
Initiated: 2016-11-18
Terminated: 2018-07-13
Firm location: Laurel, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOROhmeda Medical·cleared 2002-05-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.