LEGEND XT 4CH COMBO PKG

Additional Manufacturer Narrative

THIS UNIT SHOULD HAVE BEEN PART OF THE RECALL BECAUSE THE SOFTWARE VERSION V2.2 LOADED NEEDS TO BE UPDATED TO A HIGHER VERSION TO PREVENT FROM APPLYING HIGHER THAN EXPECTED ENERGY TO PATIENTS. ONLY APPROXIMATELY 50% OF THE RECALLED DEVICES CAME BACK TO (B)(4) FOR REPAIR OR SERVICE WHEN THE RECALL WAS TERMINATED BY THE FDA. THE CUSTOMER HAS BEEN NOTIFIED DURING THE RECALL AND FAILED TO RETURN THE DEVICE FOR SOFTWARE UPGRADE.

Description of Event or Problem

USER FACILITY BIOMED CALLED IN REGARDING ELECTROTHERAPY MACHINE E-STIM SHOCKING PEOPLE. BIOMED DOES NOT HAVE PATIENT INFO AND STATES DOCTOR DOES NOT KNOW WHICH PATIENT IT SHOCKED.