Events

Retiro De Equipo (Recall) de All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

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 Burton Medical Products Corp.

¿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
    28229
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0589-04
  • Fecha de inicio del evento
    2004-02-19
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31412
  • 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
    Device, Medical Examination, Ac Powered - Product Code KZF
  • Causa
    Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
  • Acción
    Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.

Device

All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufacture...
  • Modelo / Serial
    See Product Description
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.
  • Manufacturer
    Burton Medical Products Corp

Manufacturer

Burton Medical Products Corp
  • Dirección del fabricante
    Burton Medical Products Corp, 21100 Lassen St, Chatsworth CA 91311-4250
  • Source
    USFDA