Events

Retiro De Equipo (Recall) de Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ellex Medical Pty 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
    RC-2017-RN-00213-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-02-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00213-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The prager shell is supplied as an accessory with the ellex ‘eyecubed v4' and ‘eyeone’ ophthalmic ultrasound diagnostic device. prager shells are reusable semi critical devices requiring high level disinfection. they are required to be cleaned and disinfected before the first use and between patient uses.An issue has been identified with the manufacturer's instructions for use (ifu) for the prager shell. this ifu does not provide adequate details on the cleaning and disinfection procedures. validated cleaning and disinfection procedures, which will provide the required level of cleaning and disinfection, have been included in a revised version of the ellex prager shell care instructions. to date, there have been no adverse events reported to ellex for the prager shells.
  • Acción
    Ellex is advising customers with affected stock to ensure that cleaning and disinfection procedures of the Prager shell are performed in accordance with the “Ellex Prager Shell Care Instructions” supplied.

Device

Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit
  • Modelo / Serial
    Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe KitEllex 14.9mm OD - Prager Adult - Prager scleral shell for BiometryModel No: P-106, PRAGERADULTLot No: AA003725, 15-385, 15-393 and 16-207Ellex 12.5mm OD - Prager Child - Prager scleral shell for BiometryModel No: P-106SV, PRAGERCHILDLot No: 15-32610 MHZ Biometric A Scan Probe Kit (includes Prager Adult)Model No: 10MHZASCAN-KITLot No: 15M028, 15L049, 15M046, 15M057 and 16K050ARTG Number: 242235
  • Manufacturer
    Ellex Medical Pty Ltd

Manufacturer

Ellex Medical Pty Ltd