Advice
Regulatory information
Regulatory information
NPi-200 is a CE-marked class I medical device.
The following manufacturer field safety notices or medical device alerts for this technology have been identified:
NeurOptics NPi-200, MAUDE report number 6913426, September 2017. It was reported that the charger docking station had a design error, with the charger burning out within 60 days of operation. This was resolved in January 2018.
The Medicines and Healthcare products Regulatory Agency said that the complaint seems to be from a single device user and does not have an associated recall or other field safety corrective action from the manufacturer. The affected component is the power supply, which is likely to be different in the UK and therefore has limited relevance to the UK market.