Events

Alerte De Sécurité sur ingenia, intera, achieva and achieva dstream mr 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 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
    2014-08-12
  • Date de publication de l'événement
    2014-08-12
  • 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_20140812b.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 healthcare ingenia, intera, achieva and achieva dstream mr systems medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning its ingenia, intera, achieva and achieva dstream mr systems on r5.1 .7 and r5.1 .8 with the mobi view software option. according to the fsn, when scrolling through mobiview fused sagittal/coronal images, the actual display order of the images on the screen is opposite to previous releases. this behaviour is seen on the mr console as well as on workstations and the picture archiving and communication system (pacs). the slice numbering of fused sagittal and coronal images is reversed compared to the unfused sagittal and coronal images. as a result, source image slice 1 becomes fused image slice 9 in sagittal/coronal direction, and vice versa. the slice numbering is correct in the transverse direction. the manufacturer advises users of the followings: to avoid possible confusion, the unfused images, transverse images and anatomical landmarks should be included in reading the examination. both unfused and fused images should be exported to the pacs and workstations. furthermore, the manufacturer plans to create a field change order to install updated software in a service pack that makes the slice numbering consistent for fused and unfused images. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 12 aug 2014.

Device

ingenia, intera, achieva and achieva dstream mr systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Healthcare Ingenia, Intera, Achieva and Achieva dStream MR systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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