Events

Retiro De Equipo (Recall) de ADVIA Chemistry Halogen Lamp

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2015-RN-01148-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-11-30
  • 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-2015-RN-01148-1
  • 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
    Siemens healthcare diagnostics is conducting a recall for product correction for the advia chemistry halogen lamp (smn 10309448) in advia chemistry systems. siemens has identified specific lot numbers of the halogen lamp that may have a defect that could cause it to fail prematurely.The potential exists for a delay in testing if the halogen lamp fails prematurely. results are not impacted as the system will become inoperable when this issue occurs. the risk to health is low. siemens is not recommending a laboratory look back as a result of this issue.
  • Acción
    The sponsor Siemens is advising users to inspect unused stock and discard affected units. The sponsor will replace the affected units. If the Halogen lamp currently installed in the system fails approximately 100 hours after installation, customers are to contact the sponsor for a replacement. This action has been closed-out on 24/05/2017.

Device

ADVIA Chemistry Halogen Lamp
  • Modelo / Serial
    ADVIA Chemistry Halogen LampSiemens Material Number (SMN): 10309448Affected Lot Numbers: J411, J412, J501, J502, J503, J504, J505, J506Affected ADVIA Chemistry Systems:ADVIA 1200SMN: 10309735, 10470358, Legacy Numbers – 094-A001-02, 094-A001-03, 094-A001-04, 094-A001-05, 094-A001-06ADVIA 1800SMN: 10315183, 10322655, 10337372, 10337373, 10337374, 10337375, 10337376ADVIA 2400SMN: 10315769, 10816871, 10816872, 10816873, 10816874, 10816875, 10816876ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA