Events

Retiro De Equipo (Recall) de Device Recall Epic Critical Care Bed (Model 2031)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Stryker Medical Division of Stryker Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    61054
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1355-2012
  • Fecha de inicio del evento
    2012-03-12
  • Fecha de publicación del evento
    2012-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108024
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    Stryker medical has determined that units manufactured between september 1, 2004 through november 30, 2007, did not receive updated preventive maintenance information. (failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int.
  • Acción
    Stryker Medical sent an Urgent-Medical Device Correction letter dated March 12, 2012 to all consignees. The letter identified the affected products, problem, updated preventive maintenance information and requested the following immediate actions: 1) Locate the beds listed in this notice, 2) Ensure that the brakes are holding properly, 3) If the brakes are not holding, contact Stryker (1-800-327-0770, option 4) to order the maintenance parts, 3) Continue to periodically inspect brake functionality, as noted on enclosed preventive maintenance schedule/checklist, 4) Order replacement brake components, as needed, 5) Return the enclosed post card to confirm receipt of this notification, 6) If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location, 6) If you have disposed of any of the beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. For questions or concerns, please, contact Sandy Cliche at 269-389-6025.

Device

Device Recall Epic Critical Care Bed (Model 2031)
  • Modelo / Serial
    0409060501, 0409060502, 0409060503, 0409060504, 0409060505, 0409060506, 0409060507, 0409060508, 0409060509, 0409060510, 0409060511, 0409060512, 0409060513, 0409060514, 0409060515, 0409060616, 0409060617, 0409060618, 0409060619, 0409060620, 0409060621, 0409060660, 0409060661, 0410062541, 0410062542, 0410062543, 0410062544, 0410062545, 0410062546, 041062545, 041062546, 0411062062, 0411062063, 0411062064, 0411062065, 0411062066, 0411062067, 0411062068, 0411062069, 0411062070, 0411062071, 0411062072, 0411062079, 0411062080, 0411062081, 0411062082, 0411062083, 0411062084, 0411062085, 0411062086, 0411062087, 0411062088, 0411062089, 0411062090, 0411062136, 0411062137, 0411062138, 0411062139, 0411062140, 0411062141, 0411062143, 0411062144, 0411062145, 0411062146, 0411062147, 0411062148, 0411062149, 0411062150, 0411062151, 0411062152, 0411062153, 0411062154, 0412065012, 0412065013, 0412065014, 0412065015, 0412065016, 0412065111, 0412065112, 0412065113, 0412065114, 0412065115, 0412065116, 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  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.
  • Descripción del producto
    Stryker Critical Care Bed Model 2031, 230 V , 50/60 Hz, Max Load = 225 Kg,, Stryker, Portage, MI || Product Usage: || EPIC II (model 2031 ) Critical Care beds Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The EPIC II model is primarily used in a Critical Care environment, but may be used in Med/Surg environments. Model 2031 represent International Voltage configurations of the 2030 model respectively.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA