BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Information for the EP Shuttle Generator / EP Shuttle System 100W, Biosense Webster

Product group Medical electronics / Electromedical devices
Reference 03538/11

The company Biosense Webster, Inc. notified of a few undetected software anomalies for the EP Shuttle Generator / EP Shuttle System 100W (legal manufacturer: Stockert GmbH) with Software Versions 1.035 to 1.037. The anomalies are detailed in a Release Note.

Safety Information for the EP Shuttle Generator / EP Shuttle System 100W, Biosense Webster , Download_VeroeffentlichtAm_EN PDF, 211KB, File does not meet accessibility standards