BEUDAMED
    FDA Recall Open, Classified

    Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

    Recall: Z-0883-2026 · Initiated October 31, 2025

    Recall

    Recall Number
    Z-0883-2026
    Event Number
    97843
    Firm
    Philips Ultrasound, LLC
    FEI Number
    3019216
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 31, 2025
    Posted
    December 4, 2025
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

    Reason

    Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

    Action

    On November 1, 2025, Philips issues an Urgent Medical Device Recall (Correction) Notification to affected consignees. Phillips ask consignees to take the following actions: 1. Utilize an Android based device with your Lumify system. 2. Lightning port devices are not affected and may continue to be used as normal. 3. If you use an 05 based device, do not update your OS device to software version lax. 4. Turn off 05 auto-updates on USB host devices for Lumify by following the below steps: 5. Place this Notice with the documentation of the affected Ultrasound system(s); ensure the notice is in a place likely to be viewed by device operators. 6. Circulate this Notice to all users of the affected device(s) so that they are aware of the issue. 7. Complete the Acknowledgment form indicating you have read and understand the recall.

    Distribution

    Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras , Hungary, Iceland, India, Indonesia, Israel, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.

    Quantity

    4,819 systems