A Class I recall, the most serious of all types of safety warnings, has been initiated on a medical device that could potentially harm consumers.
The recall was announced by Nidek Medical Products and concerns their Nidek Medical Mark5 Nuvo Lite Oxygen Concentrators. 11 models of the product in total fall within the purview of the recall, and each of the devices in question will have a serial number between 042-10000 and 102-09335. Each of the devices was produced between January 2004 and May 2010.
At issue is a defect in a certain component of these items’ capacitor. The item is meant to give oxygen to people who need a steady stream in a home setting, although it is not meant to be used as a type of life support. The faulty component within the capacitors not only takes away the oxygen being supplied to an individual, it can create a dangerous fire situation that could potentially do further harm.
Already, reports of fires breaking out in nursing homes and residential addresses have come to the fore, although there have thankfully not been any reported injuries in conjunction with those situations. Nidek has stated their intentions to provide all affected persons with new capacitors that don’t suffer from the defect. Notification has reportedly already been issued to over 95% of affected consumers.