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.