Events

Retiro De Equipo (Recall) de Device Recall Volker 2080, 2082, S 280 and S 282

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 Hill-Rom, 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
    74615
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2376-2016
  • Fecha de inicio del evento
    2016-06-14
  • Fecha de publicación del evento
    2016-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148050
  • 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 current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. to date there has been one report of a related injury.
  • Acción
    Hill-Rom sent an URGENT: MEDICAL DEVICE CORRECTION letter dated June 14, 2016 to the affected US and Canadian customers via email and courier, international customers. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The letter requests the number of beds in the consignees possession so that repair kits can be provided. If you have any questions regarding this safety notice, contact Hill-Rom Technical Support at 1-800-445-3720, your distributor, your Hill-Rom representative or contact us on www.hill-rom.com.

Device

Device Recall Volker 2080, 2082, S 280 and S 282
  • Modelo / Serial
    All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, SPAIN, SWITZERLAND, and UNITED KINGDOM.
  • Descripción del producto
    Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. || A/C Powered Adjustable Hospital Bed || Product Usage: || Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Dirección del fabricante
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA