Recall Z-0363-2014— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2013-10-23, terminated 2014-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-23
- Terminated
- 2014-05-16
- Firm location
- Portage, MI, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.