G10-01 GENTUITY HF-OCT IMAGING SYSTEM

Additional Manufacturer Narrative

AFTER SOFTWARE AND BIOS UPDATES, THE CONSOLE SHOWED REPEATED STARTUP ERRORS AND THE PIM WAS NOT DETECTED. LOG REVIEW FOUND A USB COMMUNICATION ERROR. INSPECTION OF THE RETURNED UNIT IDENTIFIED A WEAK SOLDER JOINT AT CONNECTOR J12 ON THE PIM PCBA. THE PIM PCBA WAS REPLACED AND FUNCTION RESTORED. FOR CONTAINMENT OF THIS ISSUE ALL PIM PCBS IN GENTUITY INVENTORY WERE INSPECTED AND VERIFIED TO HAVE PROPER SOLDER CONNECTIONS FOR THIS CONNECTOR, J12.

Description of Event or Problem

ON14 FEB 2023: (B)(6) HEAD OFFICE: ON (B)(6) 2023 AFTER UPGRADING S/N: (B)(6) (V21.11.7 V21.11.9) AND THE BIOS UPDATE WORK, "CRITICALERROR" OCCURRED WHEN STARTING THE CONSOLE AND LOGGING INTO THE SERVICE BACKDOOR. UPON REBOOTING AFTER SHUTDOWN, THE MESSAGE DISPLAYED "THERE WAS AN ERROR STARTING THE SYSTEM. PLEASE CONTACT GENTUITY IF THE PROBLEM PERSISTS." AFTER THAT, REPEATED MANY TIMES RESTARTS, BUT SAME MESSAGE DISPLAYED ALL. "THERE WAS AN ERROR STARTING THE SYSTEM. PLEASE CONTACT GENTUITY IF THE PROBLEM PERSISTS." WHEN PERFORMED THE SOFTWARE AND FIRMWARE INSTALLATION AGAIN, THE PIM STATUS WAS NOT DISPLAYED ON THE GENSHIUI SCREEN, AND THE FIRMWARE COULD NOT BE INSTALLED. (THE OPTICALENGINE STATUS WAS DISPLAYED ON THE SAME SCREEN.) IT SEEMS THAT THE CONSOLE DOES NOT RECOGNIZE PIM. THE BACK COVER OF THE CONSOLE WAS OPENED AND THE USB CABLE AND POWER CABLE WERE REPLACED AND RECONNECTED, BUT THE SYMPTOMS REMAINED THE SAME.