Events

Retiro De Equipo (Recall) de PLASMA STERILIZER HMTS-40E

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

¿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
    22961
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-04-30
  • 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
    Results of further testing performed on the hmts sterilant agent used in these sterilizers demonstrate that the expiry date of the sterilant can be extended from 1 year to 2 years. as a result the software in the hmts plasma sterilizers must be updated in order to recognize this extended time of expiry. this recall is being initiated in order for scican technicians to perform this software update. there is no safety issue related to this recall and the units can continue to be used.

Device

PLASMA STERILIZER HMTS-40E
  • Modelo / Serial
    Model Catalog: HMTS-40E (Lot serial: All); Model Catalog: HMTS-30E (Lot serial: All); Model Catalog: HMTS-SES (Lot serial: All); Model Catalog: HMTS-80A (Lot serial: All); Model Catalog: HMTS-80E (Lot serial: All); Model Catalog: HMTS-80 (Lot serial: All); Model Catalog: HMTS-142-R (Lot serial: All); Model Catalog: HMTS-142 (Lot serial: All); Model Catalog: HMTS-142D (Lot serial: All)
  • Descripción del producto
    PLASMA STERILIZER HMTS-40E;PLASMA STERILIZER HMTS-30E;PLASMA STERILIZER - HMTS-SES;PLASMA STERILIZER - HMTS-80A;PLASMA STERILIZER HMTS-80E;PLASMA STERILIZER - HMTS-80;PLASMA STERILIZER - HMTS-142
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Dirección del fabricante
    TORONTO
  • Empresa matriz del fabricante (2017)
    Scican Ltd
  • Source
    HC