Events

Retiro De Equipo (Recall) de APS III

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 St Jude Medical CRMD.

¿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
    36619
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0296-2007
  • Fecha de inicio del evento
    2006-10-06
  • Fecha de publicación del evento
    2006-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49015
  • 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
    bradycardia and tachycardia device programmer - Product Code KRG
  • Causa
    St. jude medical has identified a low-frequency anomaly in the software used in the aps iii model 3500/3510 and merlin pcs model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator (eri) status.
  • Acción
    The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th. In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com Completion of this advisory is estimated to be three months after its initiation.

Device

APS III
  • Modelo / Serial
    All Devices (all serial numbers for the devices referenced in the advisory.)
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide in USA, ARGENTINA, AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, EUROPE, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GUATEMALA, HONG KONG, ICELAND, INDIA, ISRAEL, ITALY, JAPAN, JORDAN, SOUTH KOREA, LATVIA, LICHTENSTEIN, LUXEMBURG, MALAYSIA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PORTUGAL, SAUDI ARABIA, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, UNITED KINGDOM & VENEZUELA
  • Descripción del producto
    St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Dirección del fabricante
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA