Events

Retiro De Equipo (Recall) de Device Recall Liko Standard Slingbar 450.

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
    62413
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0622-2013
  • Fecha de inicio del evento
    2012-12-06
  • Fecha de publicación del evento
    2012-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110438
  • 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
    Liko/hill-rom has received reports from facilities which indicate that serious injuries have been received related to the standard sling bar 450. there have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). one of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use wher.
  • Acción
    Hill-rom sent an URGENT MEDICAL DEVICE RECALL notification letter dated December 6, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.. Customers were requested to please read, fill in completely, and return the Response Form to Hill-Rom immediately. This information will be compiled and reported to the applicable regulatory governing bodies. If we do not receive your response we will be required to contact you asking for your response. Continue to follow safe lifting practices, and do not allow unauthorized persons, especially children, to play around or operate the lift. If you have any questions concerning this Customer Safety Notification, please contact Hill-Rom Technical Support at 800-445-3720.

Device

Device Recall Liko Standard Slingbar 450.
  • Modelo / Serial
    The Liko Standard Slingbar 450 accessory has been supplied under multiple product numbers and combined with the sale of mobile lifts. The Standard Slingbar 450 is not serialized and has been distributed between January 1980 and the present. Here are the different Product Numbers in which the Slingbar has been shipped under: Standard Slingbar 450: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, and 5019013.  Packaged with Golvo up to April of 2005: 2000001, 2000003, 2000005, 2000006, 2000007, 2000008, 2000009, 2000009CH, 2000009D, 2000009DK, 2000009EU, 2000009F, 2000009FIN, 2000009J, 2000009N, 2000009NL, 2000009UK, 2000009U5, 2000010, 20000100, 20000100K, 2000010EU, 2000010F, 2000010FIN, 2000010H, 2000010J, 2000010N, 2000010NL, 2000010UK, 200001OU5, 2000050, 2000051, 2000061, IN8000, and IN8061.  Packaged with Viking up to December of 2004: 2040003, 2040003L, 2040004, 2040005, 2040006, 2040007, 2040013, 2040014, 2040015, 2040033, 2040034, and 2040035.  Packaged with LikoLight up to December of 2004: 2030001 and 2030001H.  Packaged with Uno lifts up to present: 2010001, 2010002, 2010003, 2010003D, 2010003EU, 2010003F, 2010003H, 2010003N, 2010003UK, 2010003US, 2010004, 2010004D, 2010004EU, 2010004F, 2010004H, 2010004N, 2010004UK, 2010004US, 2010005, 20100050, 2010005EU, 2010005F, 2010005N, 2010005UK, 2010005U5, 2010011, 2010012, 5E2010004, and 5E2010011.  Packaged with Caroli lifts up to present: 5011001.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US (nationwide) including the states of AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada, We have not yet defined our European or International facilities at this time.
  • Descripción del producto
    Liko Standard Slingbar 450. || The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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