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U.S. Department of Health and Human Services

Class 2 Device Recall FL23SE MedSurg Bed

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 Class 2 Device Recall FL23SE MedSurg Bed see related information
Date Posted September 26, 2013
Recall Status1 Terminated on January 29, 2014
Recall Number Z-2283-2013
Recall Event ID 65922
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product 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.
Code Information Model Numbers: FL23SE with nurse call option: OL235017 & OL235018
List of Affected Devices:
J60267 J60425 J60009 J60001 J60094
J60095 J60096 J60348 J60349 J60350
J60351 J60352 J60353 J60354 J60360
J60361 J60362 J60363 J60364 J60365
J60366 J60367 J60368 J60369 J60370
J60371 J60372 J60373 J60374 J60375
J60376 J60377 J60378 J60379 J60380
J60381 J60382 J60383 J60384 J60385
J60386 J60387 J60388 J60389 J60390
J60391 J60392 J60393 J60394 J60395
J60396 J60397 J60398 J60399 J60400
J60401 J60402 J60403 J60404 J60405
J60512
Recalling Firm/
Manufacturer
Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact
269-324-6609
Manufacturer 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.
FDA Determined
Cause 2
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 269-324-6609.
Quantity in Commerce 61 units
Distribution Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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