Events

Retiro De Equipo (Recall) de IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-01434-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-27
  • 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-01434-1
  • 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
    Intelerad medical systems received a complaint from a client notifying a problem that could occur on the intelepacs software. the issue is triggered when plain text reports from external sources have been modified to be html compatible, and by the presence of the less than (<) character in the report. when viewing a report, the less than character is not present while it was there in the original report received by intelepacs. in other cases, when the character is present in a combination with other characters, parts of the report text following the less than character are not displayed depending on the intelerad application used by the end-user to review the reports.There is a possibility that incomplete information is presented to the radiologist or referring physician. the absence of the information in the report could affect the decision made in relation with the patient care.
  • Acción
    Emergo is advising users who utilise reports with HTML from external sources, that the affected issue may occur depending on the HTML formatting provided by the external source. If users are affected, a review of configurations of the external source is recommended. Intelerad is advising users that a configuration change and software upgrade will be implemented as a permanent correction.

Device

IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-...
  • Modelo / Serial
    IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7ARTG Number: 149923
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia