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 healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.
FDA Recall Z-2283-2013 · Posted 2013-09-26
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Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2013-08-19
Date Terminated2014-01-29
Product Quantity61 units
Reason for Recall
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.
Firm 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 269-324-6609.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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