Medical device manufacturer, Dornier MedTech, has issued a medical device safety alert concerning its Dornier Gemini lithotripter [Serial Numbers: up to 152, as well as 158, 160 and 161].
Through customer feedback, the manufacturer received information that the level of intensity of the shock wave application has increased unintendedly during treatment. The increase of intensity while applying shock waves is only possible in the model "kV Change on the Fly".
According to the manufacturer, its investigations traced back to an ergonomical issue of the touch panel, due to which the intensity can be increased by several light hits. It is possible to trigger the release unintendedly. The intensity is still limited to the maximal allowed intensity for treatment according to the operation manual, but unintended increase may also increase the occurrence rate of known side effects.
The manufacturer decided to deactivate the failure triggering mode of "kV Change on the Fly" at the device to ensure patient safety. A service technician will conduct the necessary configurations during next service. After deactivation of the failure mode, adjustment of the intensity level during shock wave application is not allowed. The manufacturer is currently working on a solution to make the mode safely available again.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 February 2018.