Events

Rappel de UROVIEW 2800 SYSTEM - UROLOGICAL TABLE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    43457
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2008-07-02
  • 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
    Ground path on the workstation mounting bracket is suspect. single fault conditions exist that could energize the mounting bracket resulting in a noncompliance with regulatory requirements.

Device

UROVIEW 2800 SYSTEM - UROLOGICAL TABLE
  • Modèle / numéro de série
    Model Catalog: 00-870638-02 (Lot serial: S/N'S P6-0528-R P6-0390-R); Model Catalog: 00-870638-02 (Lot serial: P4-0400-R); Model Catalog: 00-870638-02 (Lot serial: P6-0404-R P6-0396-L); Model Catalog: 00-870638-02 (Lot serial: P4-0433-R P4-0376-R); Model Catalog: 00-870632-05 (Lot serial: >10 NUMBERS); Model Catalog: 2274023 (Lot serial: >10 NUMBERS); Model Catalog: 00-870632-05 (Lot serial: CONTACT); Model Catalog: 2274023 (Lot serial: CONTACT); Model Catalog: 2274023 (Lot serial: MANUFACTURER); Model Catalog: 00-870632-05 (Lot serial: MANUFACTURER); Model Catalog: 2350023 (Lot serial: S/N'S 5613PU5 3499PU1); Model Catalog: 2350023 (Lot serial: 3575PU8 3584PU0 3574PU1); Model Catalog: 2350023 (Lot serial: 3537PU8 3496PU7 4803PU3); Model Catalog: 2350023 (Lot serial: 5246PU4); Model Catalog: 00-870637-02 (Lot serial: MANUFACTURER); Model Catalog: 00-870637-02 (Lot serial: CONTACT); Model Catalog: 00-870637-02 (Lot serial: >10 NUMBERS)
  • Description du dispositif
    UROVIEW 2800 SYSTEM - UROLOGICAL TABLE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)