BEUDAMED
    FDA Enforcement Class II Terminated

    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12

    Recall: Z-2275-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2275-2019
    Event ID
    83429
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NeuroLogica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2019
    Initiation Date
    July 25, 2019
    Classification Date
    August 14, 2019
    Termination Date
    September 11, 2020
    Address
    14 Electronics Ave, N/A, Danvers, MA, 01923-1011, United States

    Description

    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12

    Reason

    There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.

    Code Info

    UDI: 08806167789220 Serial Numbers: S1C0M3HK300004A S1C0M3HK300005P S1C0M3HK300006D S1C0M3HK300007X S1C0M3HK300008N S1C0M3HK300001K S1C0M3HK300002Z S1C0M3HK400005Z S1C0M3HK400006Y S1C0M3HK400008P S1C0M3HK400001L S1C0M3HK400002T S1C0M3HK400003B S15NM3HK200005N S15NM3HK100001X S1C0M3HKC00001H S1C0M3HKC00002J S1C0M3HK900001Z S1C0M3HK900002Y S1C0M3HK900003A S1C0M3HK900004P S1C0M3HK900005D S1C0M3HK900006X S1C0M3HK900007N S1C0M3HK900008E S1C0M3HK900009F S1C0M3HK900010L S1C0M3HK900011T S1C0M3HK800001P S1C0M3HK800002D S1C0M3HK700001N S1C0M3HK700002E

    Distribution

    US Nationwide

    Quantity

    3582 worldwide