Events

Alerte De Sécurité sur LOGIQ S7 and S8

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE 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
    2013-04-18
  • Date de publication de l'événement
    2013-04-18
  • 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_20130418a.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: ge healthcare logiq s7 and s8 the united states food and drug administration (fda) has issued a medical device safety alert concerning logiq s8 (with software revisions r1.1.1 and r1.5.1) and s7 (with software revisions r1.0.1, r1.0.2 and r1.0.3) diagnostic ultrasound system with the s4-10-d ultrasound probe manufactured by ge healthcare, llc. according to the safety alert, ge healthcare has become aware of a potential safety issue due to the s4-10-d ultrasound probe used in conjunction with the logiq s8 and logiq s7 ultrasound systems. it was discovered that this issue also leads to a specification issue of the acoustic output of this probe. there is a potential for a skin burn when the flow model in the cardiac application is activated with the s4-10-d ultrasound probe. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm? action=detail&id=64725&w=04172013&lang=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 april 2013.

Device

LOGIQ S7 and S8
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Healthcare LOGIQ S7 and S8
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare