ACUSON JUNIPER ULTRASOUND SYSTEM

Additional Manufacturer Narrative

AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE # (B)(4).

Description of Event or Problem

WHILE USING THE ACUSON JUNIPER SYSTEM FOR THYROID EXAMS, THE CUSTOMER FOUND THE SR MEASUREMENT VALUES WERE INACCURATE. THIS OCCURRED WITH MULTIPLE EXAMS. IN THE DICOM SR PAGE, THE THYROID LENGTH AND WIDTH VALUES ARE TRANSPOSED AND INCORRECT IN THE DICOM SR STATEMENT. INCORRECT TRANSMISSION OF THE MEASURED LENGTH AND WIDTH OF THE THYROID GLAND IN THE SR REPORT HAS CLINICAL IMPACT, AS IT MAY CAUSE CONFUSION FOR USERS WHO REVIEW THE RESULTS. THE CUSTOMER IS CURRENTLY MANUALLY CORRECTING THE MEASUREMENT VALUES. RESCANNING OF THE PATIENTS WAS CONDUCTED DUE TO THE INCORRECT MEASUREMENTS.