Events

Retiro De Equipo (Recall) de Device Recall SIZEWise Rentals LowBoy Bed

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 Rayes Inc.

¿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
    35061
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0908-06
  • Fecha de inicio del evento
    2005-11-14
  • Fecha de publicación del evento
    2006-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45205
  • 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
    The bed may drop due to a malfunction of the actuator exceeding its stop.
  • Acción
    The recalling firm met with their one customer on/about 11/14/05 explaining the reason for correction. The customer then notified their company stores and dealers via service bulletin dated 2/28/06 that they would be receiving new acutators for replacement on the beds. The actuators were sent to their company stores and dealers in early March.

Device

Device Recall SIZEWise Rentals LowBoy Bed
  • Modelo / Serial
    The serial numbers will be listed in the following format: SIZEWise number/Wheelchairs of Kansas number  22639/212666; 23243/212849; 22493/212646; 23245/212851; 21244/212428; 21254/212438; 22132/212502; 22140/212510; 22141/212511; 22142/212512; 22139/212509; 24403/213406; 22640/212667; 21251/212435; 23227/212860; 23228/212868; 23229/212869; 23257/212878/ 24384/213086; 24385/213087; 24398/213282; 24409/213412; 21252/212436; 22128/212498; 22636/212644; 23256/212879; 22502/212655; 22630/212658; 22642/212669; 21245/212429; 22129/212499; 23262/213073; 24401/213285; 22126/212496; 22496/212649; 23232/212863; 23239/212858; 23240/212846; 24402/213286; 23226/212871; 22135/212505; 22137/212507; 23246/212852; 23247/212853; 23248/212854; 23241/212847; 23260/213071; 23274/213084; 24387/213089; 23271/213081; 24396/213080; 22635/212663; 24411/213414; 24413/213416; 24414/213417; 24415/213418; 24416/213419; 24417/213420; 24418/213421; 24419/213425; 24420/213426; 24421/213427; 24422/213428; 25360/213429; 25361/213430; 25362/213431; 25363/213432; 25364/213433; 25365/213434; 25366/213435; 25367/213436; 25368/213437; 22136/212506; 22492/212631; 22638/212665; 22643/212670; 21240/212423; 21241/212424; 21246/212430; 22631/212659; 22632/212660; 22644/212874; 22646/212872; 23261/213072; 23263/213074; 23264/213075; 23265/212875; 23267/213077; 24391/213275; 24397/213281; 24399/213283; 21242/212425; 22498/212651; 23266/213076; 24400/213284; 24407/213410; 24408/213411; 21247/212431; 22495/212648; 23231/212866; 23234/212865; 24390/213123; 24389/213122; 24388/213121; 21253/212437; 23242/212848; 22134/212504; 22138/212508; 23249/212855; 23250/212856; 23251/212857; 23258/212877; 23259/212876; 22499/212652; 22500/212653; 22501/212654; 22628/212656; 22629/212657; 23233/212864; 23236/212861; 23237/212860; 24394/213278; 24395/213279; 21240/212423; 22497/212650; 24393/213277; 24405/213408; 24406/213409; 22127/212497; 22494/212647; 23230/212867; 23238/212859; 23255/212880; 24392/213276; 21249/212433; 21255/212439; 22131/212501; 22637/212671; 23252/212969; 23254/213070; 23270/213080; 24383/213085; 24386/213088; 23235/212862; 23244/212850; 22133/212503; 23253/212970; 23269/213079; 22130/212500; 22634/212662; 22645/212873; 24404/213407; 24410/213413; 22633/212661; 23272/213082; 23273/213083.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The beds were shipped to the nationwide customers of their one consignee who is located in KS.
  • Descripción del producto
    Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS.
  • Manufacturer
    Rayes Inc

Manufacturer

Rayes Inc
  • Dirección del fabricante
    Rayes Inc, 204 W 2nd Street, PO BOX 320, Ellis KS 67637-0320
  • Source
    USFDA