BEUDAMED
    FDA Recall Terminated

    EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.

    Recall: Z-0368-2014 · Initiated October 17, 2013

    Recall

    Recall Number
    Z-0368-2014
    Event Number
    66662
    Firm
    Philips Medical Systems North America Inc.
    FEI Number
    1000524572
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 17, 2013
    Posted
    November 20, 2013
    Terminated
    July 16, 2014
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.

    Reason

    A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).

    Action

    Affected customers will be notified via the Urgent-Field Safety Notice (FSN79500286), Philips Model EPIQ 7 Ultrasound system, dated 2013 October. Customers are informed that using the International System Date Format in the Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. may result in calculation errors in Gestational Age and Established Due Date (EDD). Philips will upgrade customer systems to software version 1.1, which corrects the issue, for a free of charge.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of CT, HI, IL, IN, KY, MA, ME, MI, NC, OR, PA, TX, and WA, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Ireland, Republic of Korea, Latvia, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    306 units total (206 international; 100 in the US).