Events

Avis De Sécurité sur Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall®, Multirall® and Masterlift® Systems

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Hill-Rom.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Corrosion on ceiling mounted overhead lift rail system installations in indoor swimming pool areas this field safety notice relates to fasteners securing overhead lift rail systems to ceilings in highly chlorinated indoor pool applications. two complaints with no confirmed injuries have been reported to hill-rom that corrosion of the fasteners could lead to the rails becoming unattached and falling. to date, this has been reported to hill-rom twice with over 85,000 installations worldwide. hill-rom’s analysis has concluded that the root cause is stress corrosion cracking (scc) on the hardware. scc is a type of localized corrosion characterized by fine cracks which can propagate rapidly leading to failure of the components. scc may occur in the presence of highly chlorinated environments such as swimming pool areas. there is a small risk that continued use of the stationary lift in a chlorinated pool area could result in injuries to patients, caregivers or bystanders. .

Device

Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall®, Multirall® and M...
  • Modèle / numéro de série
  • Manufacturer
    Hill-Rom

Manufacturer

Hill-Rom