Recall Z-0363-2014 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Division of Stryker Corporation
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
| Date | Nov 19, 2013 (initiated Oct 23, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Equipment maintenance |
| Action | Stryker Medical sent a Medical Device Notification letter dated October 23, 2013, to all affected consignees. The letter described the recalled product, potential injuries associated with the side rail sticking, as well as providing preventive measures to be taken to mitigate the risk. Consignees were directed to locate the beds listed in this notice, ensure that the siderails have been inspected and adjusted, as required, continue to routinely inspect the siderails and functionality using the enclosed, enhanced product maintenance information. Problems and concerns should be addressed to |
| Quantity | 4126 units USA; 20449 inits Internationally |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.