Home / Recalls / Medical Devices
GE Healthcare, LLC recalls Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can trans
Recalled November 13, 2019 · FDA recall Z-0281-2020 · GE Healthcare
Hazard
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall. · FDA Class II
Units
59 devices (50 US, 9 OUS)
Sold at
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.
Description
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Product
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.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →