Events

Retiro De Equipo (Recall) de Janus and Janus G3 Automated Workstation

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por PerkinElmer.

¿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-01032-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-08-10
  • 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-01032-1
  • 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
    Perkinelmer have become aware that janus and janus g3 automated workstations were failing production final acceptance testing due to a ‘horizontal motion error’ message displayed on the system. further investigation concluded that two printed circuit boards (pcb) used in mdt models of janus and janus g3 were manufactured with the incorrect resistor values. this anomaly affects component part number 7101640 (pcb-quad motor controller mdt) and part number 7101647 (pcb-quad motor controller gripper). this anomaly could result in the ‘horizontal motion error’ being displayed and result in instrument down time. the affected printed circuit boards control functional movement of the instrument head and gripper. impact to any user samples is low, as the instrument clearly displays an error message, ‘horizontal motion error’.Perkinelmer field service personnel have been instructed to schedule a customer service visit to upgrade affected customer systems with revised printed circuit boards.
  • Acción
    PerkinElmer is requesting customers: 1. Be aware that there is potential for the ‘Horizontal Motion Error’ message to display which could result in instrument down time; 2. Follow guidance provided in the Janus Automated Workstation User Manual when the ‘Horizontal Motion Error’ message displays; and 3. If you have additional questions, contact PerkinElmer Technical Support for further assistance.

Device

Janus and Janus G3 Automated Workstation
  • Modelo / Serial
    Janus and Janus G3 Automated WorkstationProduct Numbers: AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001ARTG Number: 210712
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer