Events

Rappel de BAXTER 1550 HEMODIALYSIS MACHINE AND ACCESSORIES

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAXTER CORPORATION.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    25485
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2010-05-11
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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
  • Description du dispositif
    BAXTER 1550 HEMODIALYSIS INSTRUMENTS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION