Events

Retiro De Equipo (Recall) de AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER

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

¿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
    41521
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-03-04
  • 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
    Steris has identified the control board software in select amsco 400 units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. this may result in a procedure delay should the facility immediately require instruments from the cancelled processing cycle. if the processing cycle is interrupted the cycle should not be considered complete and the instruments should be reprocessed. steris has received no reports of procedure delays associated with the occurrence of these events.

Device

AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER
  • Modelo / Serial
    Model Catalog: SR010-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR020-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR310-XXXX-XXX (Lot serial: 03U11434); Model Catalog: SR320-XXXX-XXX (Lot serial: 033431406); Model Catalog: SR310-XXXX-XXX (Lot serial: 033431406); Model Catalog: SR320-XXXX-XXX (Lot serial: 03U11434); Model Catalog: SR310-XXXX-XXX (Lot serial: 083321409); Model Catalog: SR320-XXXX-XXX (Lot serial: 032831465); Model Catalog: SR310-XXXX-XXX (Lot serial: 032831465); Model Catalog: SR320-XXXX-XXX (Lot serial: 033021415); Model Catalog: SR310-XXXX-XXX (Lot serial: 033021415); Model Catalog: SR320-XXXX-XXX (Lot serial: 081251429); Model Catalog: SR310-XXXX-XXX (Lot serial: 081251429); Model Catalog: SR320-XXXX-XXX (Lot serial: 083321409); Model Catalog: SR212-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR222-XXXX-XXX (Lot serial: > 10 lot numbers contact mfg); Model Catalog: SR232-XXXX-XXX (Lot serial: > 10 lot numbers contact m
  • Descripción del producto
    AMSCO 400 SERIES PREVACUUM SMALL STEAM STERILIZER
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    HC