Events

Alerte De Sécurité sur SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System

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 Healthcare.

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
    2015-06-24
  • Date de publication de l'événement
    2015-06-24
  • 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_20150624.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: sense body coil 1.5t used with acs nt, intera 1.5t and achieva 1.5t mr system medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its sense body coil 1.5t used with acs nt, intera 1.5t and achieva 1.5t mr system. according to the manufacturer, if users do not follow the instructions for use (ifu) concerning the positioning of the sense body coil 1.5t and its cables in relation to the patient and mr bore, unintended resonances could be created via the patient or elevated coil cable temperature due to rf coupling to the quadrate body coil during an examination. this may result in patient burns. the manufacturer advised users to follow the ifu to position the affected product. according to the local supplier, only the model “achieva 1.5t (system code: 781296; serial numbers: 33532, 33162, 32691, 32680, 32787) is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2015.

Device

SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH