Events

Retiro De Equipo (Recall) de Device Recall Hoyer Hydraulic Patient Lifters

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 Joerns Healthcare 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
    34153
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0904-06
  • Fecha de inicio del evento
    2006-01-06
  • Fecha de publicación del evento
    2006-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43199
  • 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
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Causa
    A field correction is being conducted on select models of hoyer patient lifts because of hydraulic jack problems that have resulted in patient injury. the possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.
  • Acción
    A Technical Service Bulletin was distributed along with an Urgent Medical Device Correction letter providing details for checking the mounting stud. UPDATE: Sunrise Medical sent a Second Notice Urgent Medical Device Correction letter, in follow-up to the January 2006 notice, to Dealer/Distributors starting 04/26/06. This Notice updates customers as to what Sunrise''s field correction will be for the Hoyer Model Hydraulic Patient Lifts. The Notice states that use of the affected devices should be discontinued until the lift has been inspected and repaired. Dealers/Distributors that have distributed the product are to notify the user to discontinue use, if possible. If the lift needs to be used then the Dealer/Distributor is to do an interim maintenance.

Device

Device Recall Hoyer Hydraulic Patient Lifters
  • Modelo / Serial
    Devices manufactured between July 1, 2001 and December 31, 2004. Model & Serial Number (S/N) Range: C-CB-L2 (S/N''s 0301L0905) , C-HLA (S/N''s: 0110L001 to 0412L0176, 0110J194 to 0204J0795, 0205H0043 to 412H0080 , C-HLA-2T (S/N''s 0206L1296 to 0409L2483, 0206H0945 to 0409H2570), C-HLA-2 (S/N''s 0107L0030 to 0412L0524, 0110J0195 to 0201J1338, 0202H0586 to 412H0082), HML400 (S/N''s 0110L061 to 0412L0127, 0110J098 to 0208J0162, 0112H555 to 0409H2418).
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada, Asia, South America
  • Descripción del producto
    Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1. Distributed by Sunrise Medical, Inc. 7477 East Dry Creek Parkway, Longmont, CO 80503 USA.
  • Manufacturer
    Joerns Healthcare Inc.

Manufacturer

Joerns Healthcare Inc.
  • Dirección del fabricante
    Joerns Healthcare Inc., 5001 Joerns Dr, Stevens Point WI 54481-5040
  • Source
    USFDA