BEUDAMED
    FDA Recall Completed

    Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119

    Recall: Z-2484-2021 · Initiated August 6, 2021

    Recall

    Recall Number
    Z-2484-2021
    Event Number
    88514
    Firm
    Philips Ultrasound Inc
    FEI Number
    3019216
    Product Code
    IYO
    Status
    Completed
    Root Cause
    Software design
    Initiated
    August 6, 2021
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119

    Reason

    Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

    Action

    On 08/06/2021, the firm sent via certified mail an "URGENT Medical Device Correction" Notification Letter to customer informing them that due to a software defect, when reviewing or adjusting xPlane exam results, there is a potential for the ultrasound systems to become unresponsive (Lock-up) preventing users from continuing clinical use. The ultrasound system provides an error notification including method to restart and bring system back to normal use. The Recalling Firm has received a report of an ultrasound system locking up multiple times during an open cardiac procedure while using a Transesophageal Echocardiogram (TEE) transducer. Each lock-up required at least one system reboot to regain functionality. Customers are instructed to: 1) Determine the software version on their ultrasound system by: - Power up the system and allow it to complete the boot sequence; - Press Support on the right side of the control panel; - Under System Management, click System Information; - The software version is listed in the Software Information Section. 2) Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm. 3) Post this notice near the affected unit(s) for ease of reference. 4) Complete and return the response form to the Recalling Firm promptly and no later than 30 days from receipt via email to: [email protected] or fax to 1-833-512-7756. In addition, because the software defect may intermittently cause the system to lock-up when exiting Review mode, customer are asked to take the following steps to minimize the likelihood of occurrence: 1. Acquire a loop while in xPlane, xPlane Doppler, or Dual mode. 2. Do NOT adjust an imaging control (for example: Rotate, Tilt, Gain) while the loop capture is in progress.* (*If the imaging controls have been adjusted during the loop capture, Philips recommends that the system be rebooted prior to reviewing the loop in Review mode). 3. Allow the loop

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Albania, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Virgin Island, Yemen and Zambia.

    Quantity

    Total = 10,583 systems (EPIQ and Afiniti)