Z-1501-2017 Class II Terminated
FDA device recall Z-1501-2017 was initiated by Ohmeda Medical on November 18, 2016 and is designated Class II. 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 fi… The recall status is terminated (terminated July 13, 2018). Affected quantity: 5,993 (5,080 US; 913 OUS).
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