Advice
Regulatory information
Regulatory information
The superDimension Navigation System is a CE-marked class IIa medical device with class I (sterile) accessories.
The following manufacturer field safety notices or medical device alerts for this technology have been identified.
-
Medicines and Healthcare products Regulatory Agency (MHRA) 2012/007/004/081/001 (July 2012). A pre-Medtronic company field safety corrective action letter was issued for superDimension systems sold under product code AAS00016-xxx, operating Software Version 4.0-4.9, relating to a failure to recognise the locatable guide and incorrect error message display.