Events

Retiro De Equipo (Recall) de ORCHESTRA and ORCHESTRA PLUS Programmers

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-0412-2017
  • 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=150425
  • 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 and ORCHESTRA PLUS Programmers
  • Modelo / Serial
    Serial Numbers: BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD0505110I BD0507019I BC0206076G BE0611036I BB0203034G BB0011099G BB0103048G BC0408067G BD0509044I BB0012010G BD0501100G BC0206131G BD0501096G BA0006167G BB0011169G BD0510018I BD0505029I BD0505039I BB0102074G BD0507014I BB0101021G BD0506112I BA0007003G BB0010078G BB0010213G BC0206089G BC0205079G BD0501099G BA0004162G BB0011101G BD0501094G BB0103027G BB0012068G BD0507005I BB0011003G BB0011086G BC0408057G BB0012075G BA0005050G BC0303071G BD0507060I BB0010268G BB0012154G BC0303073G BA0006171G BB0011080G BC0312045G BC0206144G BD0505016I BC0206029G BB0012184G BD0505018I BC0405050G BD0501085G BD0506136I BB0011083G BB0012056G BE0611013I BD0507053I BD0505028I BC0408078G BE0603002I BE0603012I BB0011166G BB0012150G BB0012067G BB0012171G BB0011020G BC0212074G BB0010250G BD0507025I BB0203012G BD0501061G BC0206110G BE0611023I BB0011141G BD0502041G BE0611087I BB0012017G BB0010193G 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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 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