BEUDAMED
    FDA Recall 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 · Initiated December 16, 2020

    Recall

    Recall Number
    Z-0944-2021
    Event Number
    87012
    Firm
    Philips Ultrasound Inc
    FEI Number
    3019216
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2020
    Terminated
    March 15, 2023
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    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.

    Action

    On 12/16/2020, the manufacturer sent an Urgent Medical Device Correction letter (MDC) with instructions on how to turn off the Image Boost feature. Philips will resolve the issue by providing a software update, at no cost, to correct all affected EPIQ Ultrasound Systems (the update will disable the Image Boost feature when connected to an X8-2t TEE Transducer). Method of Notification - Letter (Urgent Medical Device Correction Letter in the US, Field Safety Notice in rest of the world, Distributor Letter in rest of the world). For US customers, the letters will be sent via certify mail with electronic return receipt. Philips Markets Organizations are responsible for distributing the letters outside of the US.

    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