Events

Alerte De Sécurité sur Electrical Lift Table

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par IBA Dosimetry GmbH.

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
    2015-11-27
  • Date de publication de l'événement
    2015-11-27
  • 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_20151127b.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: iba dosimetry gmbh electrical lift table medical device manufacturer, iba dosimetry gmbh, has issued a medical device safety alert concerning its electrical lift table [part number: ha03-000#002, ha03-010#002]. the manufacturer has identified a potential safety issue that may affect the performance of the electrical lift table under certain circumstances. when the lifting table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner. due to the forces involved, a person trying to stop the lifting table can be seriously injured. to prevent this error from occurring, users should follow the instruction in the section below until the problem is completely resolved. the manufacturer instructs affected users to take the following actions:- before receiving the replacement part: disconnect the mains power connection of the electrical lift table after setting up the table and blue phantom2. the table must not be connected to the mains power when its electrical functions are not in use for alignment. after receiving the replacement part: a new hand control including its cable will be sent when it is ready. the replacement instruction will be included in the shipment. users should immediately replace the original one upon receiving the shipment. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 november 2015.

Device

Electrical Lift Table
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: IBA Dosimetry GmbH Electrical Lift Table
  • Manufacturer
    IBA Dosimetry GmbH

Manufacturer

IBA Dosimetry GmbH