Z-1504-2017 Class II Terminated
FDA device recall Z-1504-2017 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 OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperatures controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. 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%).
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