Safety Alert for Liko Bathing Chair

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Liko AB.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-10-10
  • Event Date Posted
    2012-10-10
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: liko bathing chair it has come to our attention that medical device manufacturer, liko ab (a hill-rom company) has issued a field safety notice regarding all serial numbers of bathing chair with the following model numbers: 3156025 and p3156025. the liko bathing chair is an accessory to overhead lift devices. an event occurred in a public pool area in sweden where it was alleged that a patient fell out of the chair during a lift. the patient allegedly suffered serious injuries. the complaint investigation revealed the device was used without securing the safety belt, which is designed to keep the patient stabilized in the chair during the lift. the safety belt is secured to the chair and cannot be moved. it cannot be unnoticed to be used as part of the safe use of the device. the manufacturer has assessed the risk not likely to occur again in the lifetime of the device. the manufacturer has created a label reminding users to secure the patient with the safety belt and a new user instruction guide on how to safely use the chair. a modification kit including the label and an updated user guide will be sent to affected users. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 october 2012.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Liko Bathing Chair
  • Manufacturer

Manufacturer