Events

Alerte De Sécurité sur Zoom Latitude Programmer/Recorder/Monitor

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Boston Scientific Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-06-27
  • Date de publication de l'événement
    2012-06-27
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120627a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: boston scientific zoom latitude programmer/recorder/monitor the health canada posted a medical device recall notice concerning zoom latitude programmer/recorder/monitor, manufactured by boston scientific corporation. the manufacturer found that some model 3120 programmers distributed in canada are mislabeled. the affected programmers do not included software to program confient implantable cardioverter defibrillator and livian cardiac resynchronization therapy-defibrillator. the software models are model 2888 and model 2945 respectively for confient and livian. model 3120 programmers with missing model 2888 and 2945 software will not be able to interrogate or program confient/livian defibrillators until the software has been loaded. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_apr-june_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 27 june 2012.

Device

Zoom Latitude Programmer/Recorder/Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific Zoom Latitude Programmer/Recorder/Monitor
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH