Corrective Action for the HALOFLEX Energy Generator, BARRX Medical, Inc.
2012.08.20
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 05299/12
The company BARRX Medical, Inc. is conducting a corrective action which affects the HALOFLEX Energy Generator model numbers 1190A-115A and 1190A-230A. The generator possibly fails to enter “standby mode” when initially powered on. Customers are instructed to take steps for checking the device prior to initiating patient treatments. A software upgrade is scheduled.