Z-1501-2017 Class II Terminated

Recalled by Ohmeda Medical — Laurel, MD

Recall Details

Product Type
Devices
Report Date
March 29, 2017
Initiation Date
November 18, 2016
Termination Date
July 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,993 (5,080 US; 913 OUS)

Product Description

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.

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.

Distribution Pattern

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,

Code Information

See Attached Spreadsheat