Events

Field Safety Notices about Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall®, Multirall® and Masterlift® Systems

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Hill-Rom.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...

Manufacturer

Hill-Rom