Recall Z-2283-2013 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Division of Stryker Corporation
The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in health
| Date | Sep 26, 2013 (initiated Aug 19, 2013) |
| Status | Terminated |
| Reason | The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged. |
| Root cause | Device Design |
| Action | Stryker sent an Urgent Medical Device Recall Notification letter dated August 19, 2013, to all affected consignees. The notification described the affected product, reason for recall, potential hazards, and recall customer actions and reply instructions. A Stryker Representative will contact the consignees to arrange a time to repair the unit(s) and eliminate the risk of the potential interference . Urgent questions or concerns are directed to Blaine Burnett (269)389-6954. Stryker Medical business hours are Monday-Friday 8 a.m-5 p.m. (ET). For questions regarding this recall call 269-324- |
| Quantity | 61 units |
| Distribution | Worldwide Distribution - USA including MI, WI, VA and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.