Events

Retiro De Equipo (Recall) de BAXTER 1550 HEMODIALYSIS MACHINE AND ACCESSORIES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAXTER CORPORATION.

¿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
    25485
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-05-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Baxter has identified that subsequent to a prior device field correction in 2003-2004 some model 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. the correct versions of software are 4.1b (for system 4 instruments) and 3.0a (for system 3 instruments). a small number of replacement boards may also be affected.

Device

BAXTER 1550 HEMODIALYSIS MACHINE AND ACCESSORIES
  • Modelo / Serial
    Model Catalog: 6001238218 (Lot serial: 101260-01); Model Catalog: 6001238149 (Lot serial: 101260-01); Model Catalog: 5M5538 (Lot serial: 61338); Model Catalog: 6001238147 (Lot serial: 61338); Model Catalog: 6001238148 (Lot serial: 101260-01); Model Catalog: 6001238147 (Lot serial: 101260-01); Model Catalog: 5M5538 (Lot serial: 101260-01); Model Catalog: 6001238218 (Lot serial: 101256-10); Model Catalog: 6001238149 (Lot serial: 101256-10); Model Catalog: 6001238148 (Lot serial: 101256-10); Model Catalog: 6001238147 (Lot serial: 101256-10); Model Catalog: 5M5538 (Lot serial: 101256-10); Model Catalog: 6001238218 (Lot serial: 64840); Model Catalog: 6001238149 (Lot serial: 64840); Model Catalog: 6001238148 (Lot serial: 64840); Model Catalog: 6001238147 (Lot serial: 64840); Model Catalog: 5M5538 (Lot serial: 64840); Model Catalog: 6001238218 (Lot serial: 63560); Model Catalog: 6001238149 (Lot serial: 63560); Model Catalog: 6001238148 (Lot serial: 63560); Model Catalog: 6001238147 (Lot serial: 63560); Model Catalo
  • Descripción del producto
    BAXTER 1550 HEMODIALYSIS INSTRUMENTS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION