Recall Z-1509-2017— Ohmeda Medical

Name: FDA recall Z-1509-2017
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: K993407. Product: Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. 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

K993407 — OHMEDA MEDICAL OMNIBEDOhmeda Medical·cleared 2000-01-05

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 OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment

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.