Events

Safety Alert for Ergolet Hera II Bathing and Toilet Chair

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

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
    2012-04-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120420a.html
  • 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
    Field safety notice: ergolet hera ii bathing and toilet chair medical device manufacturer, ergolet aps, has issued an urgent field safety notice concerning ergolet hera ii with model numbers 041-00250, 041-00255, 041-00256, 041-00280, 041-00281 and serial numbers 1379 to 2180. after an incident and several claims regarding broken gas springs on the hera ii, ergolet has conducted a risk analysis and decided that replacement of the gas spring is necessary. according to ergolet, the back fixture of the gas spring has been known to break after a significant time of use, resulting in the chair to tilt backwards. if a patient is seated in the chair during this malfunction, head or neck injury may be resulted due to the sudden backwards movement. the gas spring has been updated with a reinforced back fixture on products with serial number 2181 and higher. the updated gas spring is compatible to all hera ii and is now available for replacement. according to the manufacturer, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Ergolet Hera II Bathing and Toilet Chair
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ergolet Hera II Bathing and Toilet Chair
  • Manufacturer
    Ergolet ApS

Manufacturer

Ergolet ApS