BEUDAMED
    FDA Enforcement Class II Terminated

    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.

    Recall: Z-0816-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0816-2015
    Event ID
    69790
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Ultrasound, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2014
    Initiation Date
    November 5, 2014
    Classification Date
    December 16, 2014
    Termination Date
    August 15, 2016
    Address
    22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States

    Description

    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.

    Reason

    When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.

    Code Info

    SERIAL NUMBERS FOR FCO 79500317-EPIQ5 system: US114B0005, US114B0006, US114C0193, US114C0209, US114C0239, US114C0240, US114C0241, US114C0271, US114C0272, US114C0273, US114C0284, US114C0286, US114C0287, US114C0308, US114C0331, US114C0334, US114C0366, US114C0751, US214C0043, US214C0106, US214C0140, US214C0143, US214C0144, US214C0416, US214C0417, US314C0199, US314C0298, US314C0447, US314C0728, US314C0745, US314C0800, US314C0801, US414C0012, US414C0066, US414C0114, US414C0157, US414C0158, US414C0159, US414C0395, US514C0081, USD13B0662, USD13C0033, USD13C0234, USD13C0290, USD13C0291, USD13C0481, USD13C0525, USD13C0526, USD13C0527, USD13C0572, USD13C0573, USD13C0584, USD13C0709, USN13B0039, USN13C0018, USN13C0182, USN13C0183, USN13C0184, USN13C0186, USN13C0206, USN13C0281, USN13C0282, USN13C0283, USN13C0284, USN13C0285, USN13C0286, USN13C0312, USN13C0361, USN13C0502, USN13C0503, USN13C0580, USN13C0654, USO13C0352, USO13C0354, USO13C0355, USO13C0356, USO13C0368, USO13C0369, USO13C0395, USO13C0396, USO13C0397, USO13C0398, USO13C0405, USO13C0453, USO13C0454, USO13C0596, USO13C0678, and USO13C0685.

    Distribution

    Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. ********************************************************************************** Worldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.

    Quantity

    88 units (42 in the US and 46 outside US)