FDA-Device2013-10-02Class II

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

Stryker Medical Division of Stryker Corporation
Hazard

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.

Sold states
Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
Affected count
61 units
Manufactured in
3800 E Centre Ave, N/A, Portage, MI, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2283-2013

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