BEUDAMED
    FDA Enforcement Class II Terminated

    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

    Recall: Z-2110-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2110-2014
    Event ID
    68756
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Ultrasound, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    July 9, 2014
    Classification Date
    July 23, 2014
    Termination Date
    November 6, 2015
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States

    Description

    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

    Reason

    The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.

    Code Info

    ****SYSTEM BASED ID IN THE US*********************** 12DD-14B7BC8B-295F, 25EB-143A3021-2864, 3E1D-145FC2CB-28AF, 5914-14544E46-2898, 5936-13FD3F20-27EA, 91B6-1437E5A0-285F, 9C64-1478F656-28E1, A1DD-14426F8B-2874, AC8B-14838041-28F6, C501-13FAF49F-27E5, CCFB-144184F1-2872, and J57B-147C2B71-28E8. *****SYSTEM BASED ID OUTSIDE THE US************************ 189A-13D31774-2796, 1B4E-13CD97D8-278B, 2B31-1486400F-28FC, 2B42-145AB87C-28A5, 2E29-13D2A227-2795, 3099-147B40D7-28E6, 3B7A-1439BAD4-2863, 4BD4-13C1AE06-2773, 4E88-13BC2E6A-2768, 50E7-149054AD-2910, 512B-13E23661-27B4, 539B-148AD511-2905, 564F-14855575-28FA, 5682-1402BEBC-27F5, 5E5A-14A05E34-2930, 5E6B-1474D6A1-28D9, 611F-146F5705-28CE, 66CB-13B63981-275C, 6BCD-14B067BB-2950, 6ED6-13D14240-2792, 73E9-149FE8E7-292F, 76F2-13C0C36C-2771, 7951-1494E9AF-2919, 7C05-148F6A13-290E, 7C16-1463E280-28B7, 7C49-13E14BC7-27B2, 7C5A-13B5C434-275B, 7EA8-14B5720A-295A, 8465-13D0CCF3-2791, 8C5F-14175D45-281E, 8F35-13BACE83-2765, 91E9-13B54EE7-275A, A46F-1493FF15-2917, B74A-1499H964-2921, C4CE-147D8B58-28EA, D798-14AE1D3A-294B, D7A9-148295A7-28F4, DA5D-147D160B-28E9, DFB4-149D9E66-292A, DFC5-147216D3-28D3, E268-14981ECA-291F, E7BF-14B8A725-2960, EA95-145C1863-28A7, ED7C-13D4H20E-2797, F598-13C3833A-2776, FDA3-13DE8BF9-27AC, and XAF4-1445A4A6-287B.

    Distribution

    Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.

    Quantity

    59 units total (12 units in the US and 47 units outside the US)