Medical device company Aimedics is pulling all units of its HypoMon sleep monitoring device off the shelves in Australia following reports that the device’s alarm does not work as well as stated.
HypoMon is a night-time device for children and young adults with Type 1 diabetes, designed to sound an alarm if the patient’s blood-sugar level drops too low while sleeping.
The Australian Therapeutic Goods Administration reported that the alarm does not sound off at the specified blood-sugar rate, and recommended that all customers stop using the device immediately.
Aimedics is offering a full refund and has set up a hot-line for customer questions about the device malfunction. The TGA advised diabetics to return to their normal diabetes management regimen, according to the recall notice.
"The Aimedics board had made this voluntary recall decision as we want to investigate further technical options to improve the HypoMon user experience," said board chairman Gordon Towell in a statement posted on the company’s website.