Events

Rappel de HALOFLEX ENERGY GENERATOR

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

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
    17236
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-09-19
  • 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
    There is a generator malfunction where haloflex energy generator failed to enter "standby mode" when initially powered-on (plugged- in and turned-on). during normal use when the device is powered-on the generator automatically sequences through a "power-on self test" to check for proper function. if the generator passes the self- test it enters standby mode displays "ready connect catheter" and is ready for use. patient injury has not been seen with this malfunction.

Device

HALOFLEX ENERGY GENERATOR
  • Modèle / numéro de série
    Model Catalog: 1190A-115A (Lot serial: 100711-003); Model Catalog: 1190A-230A (Lot serial: 100711-003); Model Catalog: 1190A-115A (Lot serial: FE103845.20); Model Catalog: 1190A-230A (Lot serial: 010410-002); Model Catalog: 1190A-115A (Lot serial: 010410-002); Model Catalog: 1190A-230A (Lot serial: 111209-009); Model Catalog: 1190A-115A (Lot serial: 111209-009); Model Catalog: 1190A-230A (Lot serial: 090909-009); Model Catalog: 1190A-115A (Lot serial: 090909-009); Model Catalog: 1190A-230A (Lot serial: 010410-001); Model Catalog: 1190A-115A (Lot serial: 010410-001); Model Catalog: 1190A-230A (Lot serial: 100711-005); Model Catalog: 1190A-115A (Lot serial: 100711-005); Model Catalog: 1190A-230A (Lot serial: 100711-004); Model Catalog: 1190A-115A (Lot serial: 100711-004); Model Catalog: 1190A-230A (Lot serial: FE103845.20)
  • Description du dispositif
    HaloFlex Energy Generator
  • Manufacturer
    BARRX MEDICAL INC.

Manufacturer

BARRX MEDICAL INC.
  • Adresse du fabricant
    SUNNYVALE
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC