Events

Rappel de Mako Internal cPCI Card Cage

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

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-00857-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-11
  • 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-00857-1
  • 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
    Stryker has determined that during assembly of the cpci card cage, a potential cross threading of the 3.3 vdc lug may exist. visual inspection did not confirm the assembly error. this condition could result in an intermittent power connection in the cpci card cage and abnormal system behaviour or a total loss of power. powering down of the system due to intermittent or total loss of power is estimated to have a probability of occurrence at 0.0022%. this would make the system temporarily unavailable. potential harms resulting in this failure mode are extended surgical time of =15 minutes or extended surgical time of >30 minutes.
  • Action
    Stryker is requesting customers: 1. Inform users of this Recall for Product Correction and forward the notice supplied to all internal staff who need to be aware of this issue; 2. A Stryker representative will coordinate a time for the inspection and, if necessary, replace the cPCI Unit. The Mako may continue to be used in the meantime; 3. Complete the supplied “Recall for Product Correction Notification Response” form to acknowledge you have seen this letter. Return the completed form to Stryker by email to recalls@stryker.com or fax on (02) 9467 1325; and 4. If affected stock could have been transferred from your hospital to another location, please immediately let them know of this recall action.

Device

Mako Internal cPCI Card Cage
  • Modèle / numéro de série
    Mako Internal cPCI Card CageItem Number: 201337Lot Number: 05212015ARTG Number: 223105
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA