Events

Retiro De Equipo (Recall) de Styker Impression Mattress

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
    58487
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2240-2011
  • Fecha de inicio del evento
    2011-04-29
  • Fecha de publicación del evento
    2011-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99454
  • 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
    Non-powered flotation therapy mattress - Product Code IKY
  • Causa
    Affected mattresses may not conform to federal flammability standards.
  • Acción
    Stryker Medical sent an URGENT MEDICAL DEVICE RECALL letter dated April 29, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate all affected mattresses , remove the existing mattress cover, and replace it with an enclosed mattress cover. Customers were then to notify Stryker to confirm repairs. If the mattresses were loaned or sold, Stryker requested customers to notify the new user of the recall. Customers with questions or concerns, were asked to call 269-389-6689.

Device

Styker Impression Mattress
  • Modelo / Serial
    Model number 2980: 09AC000234, 09AC000235, 09AC000236, 09AC000237, 09AC000238, 09AC000239, 09AC000240, 09AC000241, 09AC000242, 09AC000243, 09AC000244, 09AC000245, 09AC000246, 09AC000247, 09AC000248, 09EA000807, 09EA000808, 09EA000809, 09EA000810, 09EA000811, 09EA000812, 09EA00081, 09EA000814, 09EA000815, 09EA000816, 09EA000817, 09EA000818, 09EA000819, 09EA000820, 09EA000821, 09EA000822, 09EA000823, 09EA000824, 09EA000825, 09EA000826, 09EA000827, 09EA000828, 09EA000829, 09EA000830, 09EA000831, 09FA000833, 09FA000834, 09FA000835, 09FA000836, 09FA000837, 09FA000838, 09FA000839, 09FA000840, 09FA000841, 09FA000842, 09FA000843, 09FA000844, 09FA000845, 09FA000846, 09FA000847, 09FA000848, 09FA000849, 09FA000850, 09FA000851, 09FA000852, 09FA000853, 09FA000854, 09FA000855, 09FA000856, 09FA000857, 09FA000858, 09FA000859, 09FA000860, 09FA000861, 09FA000862, 09FA000863, 09FA000864, 09FA000865, 09FA000866, 09FA000867, 09FA000868, 09FA000869, 09FA000870, 09FA000871, 09FA000872, 09FA000898, 09FA000899, 09FA000900, 09FA000901, 09FA000902, 09FA000903, 09GA000920, 09GA000921, 09GA000922, 09GA000923, 09GA000924, 09GA000925, 09GA000926, 09GA000927, 09GA000928, 09JA001517, 09JA001518, 09JA001519, 09JA001520, 09JA001521, 09JA001522, 09JA001523, 09JA001524, 09JA001561, 09JA001562, 09JA001563, 09JA001564, 09JA001565, 09JA001566, 09JA001567, 09JA001568, 09JA001569, 09JA001570, 09JA001571, 09JA001572, 09JA001573, 09JA001574, 09JA001575, 09JA001576, 09JA001577, 09JA001578, 09JA001579, 09JA001580, 09JA001581, 09JA001582, 09JA001583, 09JA001584, 09JA001585, 09JA001586, 09JA001587, 09JA001588, 09JA001589, 09JA001590, 09JA001591, 09JA001592, 09JA001593, 09JA001594, 09JA001595, 09JA001596, 09JA001597, 09JA001699, 09JA001700, 09JA001701, 09JA001702, 09JA001703, 09JA001704, 09KA002025, 09KA002026, 09KA002064, 09KA002065, 09KA002066, 09KA002067, 09KA002068, 09KA002069, 09KA002070, 09KA002071, 09KA002072, 09KA002073, 09KA002074, 09KA002075, 09KA002076, 09FA000896, 09FA000897, 09AC000249, 09AC000250, 09AC000251, 09AC000252, 09AC000253, 09DA000598, 09DA000599, 09EA000832, 09HA0001046, 09HA0001047, 09HA0001048, 09HA0001049, 09HA0001050, 09HA0001051, 09HA0001052, 09HA0001053, 09HA0001054, 09HA0001055, 09HA0001056, 09HA0001057, 09HA0001058, 09HA0001059, 09HA0001060, 09HA0001061, 09HA0001062, 09HA0001063, 09HA0001064, 09HA0001065, 09HA0001066, 09HA0001067, 09HA0001068, 09HA0001069, 09HA0001070, 09HA0001071, 09HA0001072, 09HA0001073, 09HA0001074, 09HA0001075, 09HA0001076, 09HA0001077, 09HA0001078, 09HA0001079, 09HA0001080, 09JA001698, 09JA001705, 09JA001706, 09JA001707, 09JA001708, 09HA001292 and 09HA001305.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including California and the country of Canada.
  • Descripción del producto
    Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. || The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress.
  • 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