Events

Retiro De Equipo (Recall) de WIZARD2 GAMMA COUNTER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PERKINELMER HEALTH SCIENCES CANADA 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
    43413
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-06-12
  • 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
    Manufacturer has become aware through a customer complaint that the content of the second of the two #023 barcode id labels provided on each page of the barcode id label binder are incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. in the event measurement protocols have been programmed for both id #023 and #024 and the wizard2 gamma counter scans the affected barcode label the protocol associated with barcode id #024 is executed. if the error is undetected the wizard2 gamma counter may produce erroneous results.

Device

WIZARD2 GAMMA COUNTER
  • Modelo / Serial
    Model Catalog: 2470-0150 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2480-0010 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0150 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0020 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0100 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0100 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0010 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0050 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0050 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    WIZARD2 GAMMA COUNTER
  • Manufacturer
    PERKINELMER HEALTH SCIENCES CANADA INC.

Manufacturer

PERKINELMER HEALTH SCIENCES CANADA INC.
  • Dirección del fabricante
    WOODBRIDGE
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    HC