Alerte De Sécurité sur Liko Standard SlingBar 450

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

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
    2013-05-20
  • Date de publication de l'événement
    2013-05-20
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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: liko standard slingbar 450 it has come to our attention that medical device manufacturer, liko, has initiated a field safety corrective action concerning standard slingbar 450. the affected product numbers are 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043 or 5019013 (distributed between jan 1980 and nov 2012). the affected product numbers may be bundled with the golvo 1000, 3000, and 7000 series lifts, viking m, viking l, likolight 100 & 125, caroli 101, and uno 100, 101 & 102. the manufacturer has become aware of a safety issue related to the standard slingbar 450, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver or bystander could result from tripping or otherwise falling into the sling bar, typically when the lift is parked or stored when not in use. the sling hook on the end of the sling bar could pierce a body structure such as the head, shoulder or groin. the manufacturer advises users to continue to follow safe lifting practices, and not to allow unauthorized persons, especially children, to play around or operate the lift. the current standard slingbar 450 model is designed in such a way that impalement may occur. liko has designed a safety cover to put on the top of the sling bar in order to reduce the risk of impalement. the manufacturer will provide affected customers modification kits. the customers will implement the correction themselves. where needed, a hill-rom technician or third party will complete the correction. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 may 2013.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Liko Standard SlingBar 450
  • Manufacturer

Manufacturer