Medical device recalls Moderate risk

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 Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examin…
Recall number
Z-1501-2017
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 Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers except for Panda and Giraffe Warmers. It is not intended for use to support surgical field lighting.

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