Description of Event or Problem · 0
HOLOGIC IS NOTIFYING YOU OF A POTENTIAL DISPLAY ISSUE THAT CAN OCCUR ON THE GENIUS TM DIGITAL DIAGNOSTICS SYSTEM IF THE DISPLAY SETTINGS ON THE GENIUS TM REVIEW STATION MONITOR (HOLOGIC PART NUMBER (B)(4) HAVE BEEN CHANGED FROM THE ORIGINAL CONFIGURATION. UPON RECEIPT OF THIS LETTER, YOU ARE REQUIRED TO PROMPTLY COMPLETE THE ONLINE CUSTOMER RESPONSE FORM (CRF). COMPLETION OF THE CRF IS REQUIRED TO SUPPORT HOLOGIC'S FIELD CORRECTION. HOLOGIC HAS IDENTIFIED THAT DISPLAY PERFORMANCE OF THE MONITOR MAY BE AFFECTED IF USERS HAVE CHANGED THE DISPLAY OR CALIBRATION PARAMETERS FROM THOSE ORIGINALLY CONFIGURED. EXAMPLES INCLUDE ACTIONS SUCH AS DISABLING MANUFACTURER-INSTALLED DISPLAY MANAGEMENT FEATURES, MODIFYING CALIBRATION OR COMPLIANCE TEST BEHAVIOR, OR CHANGING OTHER DISPLAY-RELATED SETTINGS. ANY CHANGES TO THESE SETTINGS ARE NOT PERMITTED AND CONSTITUTE OFF-LABEL USE OUTSIDE THE APPROVED AND VALIDATED CONFIGURATION. HOLOGIC HAS NOT EVALUATED SYSTEM PERFORMANCE AT OFF-LABEL CONFIGURATIONS. THE GENIUS TM REVIEW STATION MONITOR IS INTENDED FOR USE ONLY WITH THE ORIGINAL CONFIGURATION AND INSTALLATION SETTINGS. PLEASE REFER TO THE GENIUS TM REVIEW STATION OPERATOR'S MANUAL, WHICH STATES: CAUTION: DO NOT CHANGE ANY OF THE SCREEN DISPLAY SETTINGS ON THE MONITOR. THE REVIEW STATION IS DESIGNED TO PRESENT IMAGES ON THE MONITOR AS INSTALLED BY HOLOGIC SERVICE PERSONNEL. AT THIS TIME, HOLOGIC IS NOT AWARE OF CONFIRMED PATIENT HARM OR CONFIRMED DIAGNOSTIC IMPACT ASSOCIATED WITH THIS ISSUE; HOWEVER, STRICT ADHERENCE TO THE APPROVED CONFIGURATION IS REQUIRED. THIS NOTIFICATION IS BEING ISSUED AS A PRECAUTIONARY MEASURE TO ENSURE CONTINUED USE OF THE SYSTEM IN ITS APPROVED CONFIGURATION. ACTIONS REQUIRED BY THE CUSTOMER/USER IF YOU ARE RECEIVING THIS NOTIFICATION, OUR RECORDS INDICATE THAT YOU HAVE RECEIVED A GENIUS¿ REVIEW STATION MONITOR (B)(4). AS THIS FIELD CORRECTION APPLIES TO ALL MONITORS, PLEASE FOLLOW THE INSTRUCTIONS BELOW AND COMPLETE THE CUSTOMER RESPONSE FORM (CRF) USING THE LINK OR QR CODE PROVIDED BELOW. IF YOU ARE A DISTRIBUTOR OR OTHERWISE SUPPLY GENIUS TM REVIEW STATION MONITORS TO DOWNSTREAM CUSTOMERS, YOU ARE RESPONSIBLE FOR PROMPTLY FORWARDING THIS NOTIFICATION TO ALL AFFECTED SUB-ACCOUNTS AND ENSURING COMPLETION OF THE CRF FOR EACH END-USER SITE. NO TESTING RESULTS WERE IMPACTED AS A RESULT OF THIS NOTIFICATION.