BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Field Safety Notice for Navigation Headset Operator's Manual, GE Healthcare

Product group Radiological technology
Reference 04641/09

GE Healthcare has issued a Field Safety Notice concerning the Navigation Headset Operator's Manual update for the following surgical navigation systems: OEC IT3000, IT2500, IT2500 Plus, IT3500, IT3500 Plus, ConneCTstat and ConneCTstat Plus. The ENT registration Headset must not be used in the inverted position for any CT scans or surgical procedures.

Field Safety Notice for Navigation Headset Operator's Manual, GE Healthcare , Download_VeroeffentlichtAm_EN PDF, 71KB, File does not meet accessibility standards