Events

Retiro De Equipo (Recall) de ORCHESTRA PLUS Programmer

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 Sorin Group USA, 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
    75456
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0413-2017
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150426
  • 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
    Programmer, pacemaker - Product Code KRG
  • Causa
    Sorin group usa, inc. announces a voluntary field action for the orchestra programmer and orchestra plus programmer because the residual longevity estimate may be less accurate.
  • Acción
    The firm, LivaNova, sent an "Urgent Field Safety Notice" dated 9/29/2016 to its customers. The notice described the product, problem, actions to be taken. The notice states that a Sorin representative will contact customers to upgrade the software in the facility's programmer. If customers have any questions, they are urged to call their LivaNova representative or contact LivaNova Technical Services at 877.663.7674.

Device

ORCHESTRA PLUS Programmer
  • Modelo / Serial
    Serial Numbers: NB1006418K NB1107409K NB1203456K NB1107407K NB1105419K NB0908405K NB1202447K NA0804365K NB1201447K NA0807425K NB0909407K NB1112470K NB0909402K NB1112474K NB1112444K NB1201403K NB1201402K NB1102423K NB1112471K NA0804393K NB1203431K NA0804389K NB1004403K NB1202418K NB1108403K NB1007410K NB1105438K NA0804367K NB1102406K NA0804384K NB1202458K NA0804321K NB1006415K NB1201455K NB1102402K NB1107417K NB1109421K NB1202454K NC1503413K NA0804353K NB1112482K NB1108404K NB1105436K NB0907430K NB1112485K NA0804343K NB1109418K NB1104409K NB1112414K NB0908415K NB1112407K NB1108425K NB1006402K NB1203428K NA0804426K NA0804390K NB0911402K NB0907419K NB0909417K NB1203415K NB1201442K NA0804363K NB0911414K NB0908411K NB0910412K NA0807414K NA0804387K NB1102405K NB1201409K NB1201423K NB1004416K NB1108401K NB1002406K NB1203429K NB0907433K NB1202474K NB1103415K NB1112427K NB1202462K NB1202469K NA0804319K NB1102425K NA0804339K NB1003402K NB1102404K NB0909410K NB0911404K NB1108429K NB1203444K 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
  • Descripción del producto
    The ORCHESTRA PLUS Programmer || A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Dirección del fabricante
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA