Events

Retiro De Equipo (Recall) de STATIM 7000 CASSETTE STERILIZER

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
    105113
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-01-20
  • 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
    This recall has been initiated due to a part that is no longer available. this part is an rfid (radio-frequency identification) tag which is used in the chamber seal to monitor the number of cycles ran in order to inform the user when it is necessary to change the chamber seal. our current supplier of this part has decided to exit the rfid tag business and a suitable replacement was not found. therefore all future cassette seals will no longer contain the rfid tag (seals are regularly replaced by the user). when this tag ?s not present the machine will not allow a cycle to start with the current software. ln order to implement this change in the stat/m 7000 and remove the rfid tag from the cassette seal the rfid board software must be updated to allow the unit to run without an rfid tag in the cassette seal. this will be performed by trained technicians at the user site. there is no need for the unit to be returned to the manufacturer for this software update. the life of the seal is still 1000 cycles or every twelve months whichever comes first but no notification will be given on the unit once the tag is no longer present and the software has been updated. it will be the user's responsibility to monitor the number of cycles ran and the seal's performance. manual monitoring of seal replacement is a common practice for most steam sterilizers on the market.

Device

STATIM 7000 CASSETTE STERILIZER
  • Modelo / Serial
    Model Catalog: 01-702100 (Lot serial: >10 contact mfg.); Model Catalog: 01-702101 (Lot serial: >10 contact mfg.); Model Catalog: 01-702101-R (Lot serial: >10 contact mfg.); Model Catalog: 01-702101-L (Lot serial: >10 contact mfg.)
  • Descripción del producto
    STATIM 7000 CASSETTE STERILIZER
  • Manufacturer
    SCICAN LTD.

Manufacturer

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