FDA-Device2013-11-27Class II
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
Stryker Medical Division of Stryker Corporation
Hazard
It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.
Affected count
4126 units USA; 20449 inits Internationally
Manufactured in
3800 E Centre Ave, Portage, MI, United States
Products
Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0363-2014Don't want to check this manually?
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