Events

Recall of Device Recall FL23SE MedSurg Bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Division of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65922
  • Event Risk Class
    Class 2
  • Event Number
    Z-2283-2013
  • Event Initiated Date
    2013-08-19
  • Event Date Posted
    2013-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120936
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 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.
  • 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.

Device

Device Recall FL23SE MedSurg Bed
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
  • Product Description
    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.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA