GE Healthcare, LLC recalls Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can tran…

Recall date

July 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0281-2020

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide distributions - US Nationwide in the states of CA, CT, FL, ID, IL, KS, MI, NC, NC, NJ, NM, PA, TX, VA. Countries of China, France, Germany, Korea, Republic of China.

Why it was recalled

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

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 OmniBed Carestation CS1 - Product Usage: 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.