BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Corrective Action for Licox CMP Catheter Kits, GMS

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 03447/13

Integra LifeSciences has issued a Field Safety Notice concerning a corrective action of the Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits manufactured by GMS, Gesellschaft für medizinische Sondentechnik mbH. The affected sets may contain a hex wrench that does not loosen the set screw on the drill bit. There is the risk that the clinical procedure will be delayed.
The faulty products will be replaced.

Corrective Action for Licox CMP Catheter Kits, GMS , Download_VeroeffentlichtAm_EN PDF, 101KB, File does not meet accessibility standards