Urgent field notification on generators from Biosense for RF ablation
2005.02.24
Product group Medical electronics / Electromedical devices
Reference 01704/04
The company Biosense Webster notified customers of the STOCKERT RF generator that all devices have to be updated to the latest software version due to a potential safety issue. All generators with software version other than 1.034b may not be used any longer. In a follow-up action the company informed on an issue with the new software version 1.034b. There is a possibility that power and temperature settings can alter unintentionally.