Ohmeda Medical product recalled over fire hazard

Recall date

November 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ohmeda Medical recalls Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide hea…

Recall number

Z-1505-2017

FDA classification

Class II

Brand / firm

Ohmeda Medical

Sold / distributed

Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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%).