Recall Z-1501-2017— Ohmeda Medical
Class II · Terminated
Class II FDA medical device recall by Ohmeda Medical, initiated 2016-11-18, terminated 2018-07-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.