BEUDAMED
    FDA Enforcement Class II Terminated

    Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA

    Recall: Z-0944-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0944-2021
    Event ID
    87012
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Ultrasound Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2021
    Initiation Date
    December 16, 2020
    Classification Date
    February 1, 2021
    Termination Date
    March 15, 2023
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States

    Description

    Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA

    Reason

    The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.

    Code Info

    All EPIQ Systems with software version 7.0 Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi

    Distribution

    US - AL, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE,NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI and WV OUS- Austria, Australia, Belgium, Canada, Chezh Republic, Croatia, Denmark, Egypt, Finland, France, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Latvia, Lithuania, Malta, Mexico, Netherlands, Norway, Poland, Romania, Russia, Senegal, Slovenia, Sri Lanka, South Africa, Switzerland, Thailand, Turkey, UAE and United Kingdom.

    Quantity

    607 units