Events

Alerte De Sécurité sur adac argus gamma camera systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Philips Medical Systems Cleveland Inc.

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
    2013-11-11
  • Date de publication de l'événement
    2013-11-11
  • 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_20131111.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: philips adac argus gamma camera systems the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning adac argus gamma camera systems manufactured by philips medical systems cleveland inc. products with serial numbers a01100227 and 9807143 are affected. a recent investigation has determined that visual inspections of the fork joints behind the detector that is conducted during six month preventive maintenance may not detect small cracks or deficiencies in the fork weldment. a failure in the fork weldment has the potential to cause the detector assembly to detach, resulting in serious injury or death to a patient, operator or service personnel member if he or she is in the direct path of the detector assembly when the weldment fails. philips is informing the customers to immediately cease the use of the affected systems. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01149-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2013.

Device

adac argus gamma camera systems

Manufacturer

Philips Medical Systems Cleveland Inc
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH