Events

Alerte De Sécurité sur Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software

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
    2014-05-08
  • Date de publication de l'événement
    2014-05-08
  • 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_20140508a.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 multiva mr systems using r5.1.1 and r5.1.2 version of software medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its ingenia, intera, achieva and multiva mr systems on r5.1.1 and r5.1.2 with the mobiview software option. according to the manufacturer, the cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing. the cross reference lines are correctly displayed on the unfused stations. the problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. in such situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images. the hazard is only expected in spine examinations, when using a whole spine survey, while the cervical spine is skipped for the clinical scan. there is a risk of misdiagnosis which could lead to incorrect therapy. the risk occurs when cross-reference lines on fused images are relied upon to determine location of transversal images. in mobiview applications other than spine, reference lines are not commonly used to identify or label anatomy because anatomical landmarks are used instead. the manufacturer advises affected users not to perform planning or review planning of transversal images on fused sagittal images which were generated through mobiview post-processing. instead, the planning of transversal scans should only be reviewed on the unfused stations. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 08 may 2014.

Device

Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Healthcare Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software
  • Manufacturer
    Philips Healthcare

Manufacturer

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