Description of Event or Problem · 0
SIEMENS PROVIDED NOTIFICATION OF A CORRECTIVE ACTION REQUIRED FOR A POSITRON EMISSION TOMOGRAPHY / COMPUTED TOMOGRAPHY MACHINE. THIS CORRECTIVE ACTION INCLUDED MICROSOFT HOT FIXES FOR CYBERSECURITY FIXES. HOWEVER, WHEN QUERIED, THE VENDOR WAS UNABLE OR UNWILLING TO PROVIDE DOCUMENTATION OR DETAILS TO THE CUSTOMER ABOUT WHICH COMMON VULNERABILITIES AND EXPOSURES, WHICH VULNERABILITIES, OR WHICH ISSUES WERE ADDRESSED IN THE PATCH. ADDITIONALLY, THE VENDOR REQUIRED A PURCHASE ORDER FOR (B)(6) FOR THE UPDATES - EVEN THROUGH THE SYSTEM WAS ON FULL SERVICE AGREEMENT. PER STATEMENTS FROM THE FDA, CYBER FIXES ARE TO BE COMMUNICATED CLEARLY TO HDOS SO THEY CAN IDENTIFY THE RISKS THEY ARE MITIGATING AND SHOULD BE PROVIDED AT NO COST. NOTIFICATION AND DETAILS ARE BELOW: INITIAL EMAIL NOTIFICATION: SUBJECT: MEDICAL DEVICE CORRECTION (B)(4)¿ TIME SENSITIVE DEAR CUSTOMER, IN THE INTEREST OF EQUIPMENT SAFETY AND PERFORMANCE, SIEMENS HEALTHINEERS HAS ISSUED CORRECTIVE ACTIONS AFFECTING FUNCTIONAL LOCATION (B)(4) AT (B)(6): NOTIFICATION DESCRIPTION DURATION 400501891869 UI-MI503/25/R VG80C_UD06 1.0 H WE REQUEST THAT YOU SCHEDULE CORRECTIVE ACTIONS AS SOON AS POSSIBLE. YOU MAY CONTACT YOUR CUSTOMER CARE REPRESENTATIVE DURING NORMAL BUSINESS HOURS DIRECTLY AT 1-800-888-7436, EXT: (B)(6). YOU CAN ALSO REPLY TO THIS EMAIL WITH AVAILABLE DATES AND TIMES. WE APPRECIATE YOUR PROMPT ATTENTION TO THIS MATTER. UPON REQUESTING DETAILS FROM THE SERVICE TEAM, THE ONLY INFORMATION PROVIDED IS BELOW IF YOU WANT TO HAVE IT COMPLETED, YOU WILL NEED A PO FOR (B)(6) DURING NORMAL HOURS, OR (B)(6) AFTERHOURS. THE NOTES BELOW ARE EVERYTHING REGARDING THE UPDATE. THE ONLY OTHER NOTES AVAILABLE TO SHARE ARE BELOW REASON FOR THE UPDATE VG80C_UD01 IS A REQUIRED MANUAL INSTALL AND UD'S WILL RESUME BEING CUMULATIVE AT VG80C_UD02, DETAILS REGARDING EACH UD ARE AS FOLLOWS. UD02 SW UPDATE INCLUDES: INTEGRATION OF SYNGO VS23A_HF25 (MICROSOFT HOT FIXES FOR CYBERSECURITY FIXES) CLINICAL FIXES FOR ONE CUSTOMER COMPLAINT - IMPROVEMENT IN QUALITY GUARD FEATURE TO PREVENT LSO QC FAILURE. DEFECT FIX FOR IMPROVEMENTS IN RUH INSTALL USE CASE. UD03 SW UPDATE INCLUDES: INTEGRATION OF SYNGO VS23A_HF26 (MICROSOFT HOT FIXES FOR CYBERSECURITY FIXES) CLINICAL FIXES FOR A CUSTOMER COMPLAINT - SOFTWARE HAS SOME SPANISH ENTRIES IN FRENCH USER INTERFACE. DEFECT FIX FOR IMPROVEMENTS IN RUH INSTALL USE CASE. UD04 SW UPDATE INCLUDES: INTEGRATION OF SYNGO VS23A_HF27 & VS23A_HF28 (MICROSOFT HOT FIXES FOR CYBERSECURITY FIXES) CLINICAL FIXES FOR A CUSTOMER COMPLAINT ¿ WAVEFORM GENERATION FREEZE ON MARS BOX AND PET QC FREEZE ISSUE DUE TO LOW DISK SPACE. DEFECT FIX FOR TIMING IMPROVEMENT IN DAILY QC AND LINGUISTIC SIGN-OFF QUALITY CONTROL PARAMETER UPDATE. UD05 SW UPDATE INCLUDES: INTEGRATION OF SYNGO VS23A_HF29 (MICROSOFT HOT FIXES FOR CYBERSECURITY FIXES) CLINICAL FIXES FOR A CUSTOMER COMPLAINT ¿ RECONSTRUCTION FAILS FOR STEP AND SHOOT ACQUISITION AND IMAGE LOAD ERROR IN TRUED. DEFECT FIX FOR LOG INTERPRETER & SCAP FINDINGS FOR USER RIGHT ASSIGNMENT. UD06 SW UPDATE INCLUDES: INTEGRATION OF SYNGO VS23A_HF30 (MICROSOFT HOT FIXES FOR CYBERSECURITY FIXES) ¿ DEFECT FIX FOR MSI AND SYNGO CERTIFICATE UPDATES & UD VERSION FIX IN REGISTRY.