Events

Rappel de Janus and Janus G3 Automated Workstation

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par PerkinElmer.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01032-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-08-10
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01032-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Janus and Janus G3 Automated WorkstationProduct Numbers: AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001ARTG Number: 210712
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer