Events

Retiro De Equipo (Recall) de Device Recall Liko Universal SlingBars

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
    74107
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1916-2016
  • Fecha de inicio del evento
    2016-03-08
  • Fecha de publicación del evento
    2016-06-07
  • 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=146295
  • 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
    The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. if the sling bar is not used as intended the bolt may be weakened. if the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. this hazard could cause potentially minor to catastrophic injuries to a patient.
  • Acción
    On 3/8/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected US customers via email and courier. On 3/24/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Canadian customers via email and courier. On 3/29/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Global customers via email and Docapost. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification provided new instructions for users with a lift manufactured prior to 11/19/2013, instructed the user on how to inspect for damage, and offers replacement at a 50% reduction in cost. If you have any questions concerning this Field Safety Notice, please contact Hill-Rom Technical Support, your distributor, or your Hill-Rom representative.

Device

Device Recall Liko Universal SlingBars
  • Modelo / Serial
    All Slingbars that are affected by this field action (in the table below) have been distributed within the following serial number range: 1200101 to 1370151  Model Product/Model # Universal SlingBar" 350, 3156074 Universal SlingBar" 350 QRH, 3156084 Universal SlingBar" 350 R2R, 3156094 Universal SlingBar" 450, 3156075 Universal SlingBar" 450 QRH, 3156085 Universal SlingBar" 450 R2R, 3156095 Universal SlingBar" 600 3156076 Universal SlingBar" 600 QRH 3156086
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide and US Nationwide Distribution AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , IE , IL , IN , IR , IS , IT , JO , JP , KR , KW , LB , LI , LK , LT , LU , LV , LY , MA , MT , MX , MY , NL , NO , NZ , OM , PH , PK , PL , PT , QA , RO , RS , RU, SA , SE , SG , SI , SK , SY , TH , TN , TR , TW , UA , US , UY and ZA.
  • Descripción del producto
    Liko Universal SlingBars || Universal SlingBar" 350, || Universal SlingBar" 350 QRH, || Universal SlingBar" 350 R2R, || Universal SlingBar" 450, || Universal SlingBar" 450 QRH, || Universal SlingBar" 450 R2R, || Universal SlingBar" 600 || Universal SlingBar" 600 QRH || Component of Liko Lifts || Product Usage: || Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).
  • 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