THOR PHOTOMEDICINE LTD

Additional Manufacturer Narrative

TEMPERATURE TESTING PERFORMED ON S2160 810 CLUSTER S/N (B)(6) - THIS WAS WITHIN ACCEPTED SPECS. HOWEVER, CABLE REQUIRED REPLACEMENT. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

Description of Event or Problem

810 CLUSTER PROBE OVERHEATS AFTER 3 MINS, NEEDS TO STAY OFF FOR AT LEAST 3-5 MINUTES.