Events

Retiro De Equipo (Recall) de HALOFLEX ENERGY GENERATOR

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

¿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
    17236
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-09-19
  • 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
    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
  • Modelo / Serial
    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)
  • Descripción del producto
    HaloFlex Energy Generator
  • Manufacturer
    BARRX MEDICAL INC.

Manufacturer

BARRX MEDICAL INC.
  • Dirección del fabricante
    SUNNYVALE
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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