BEUDAMED
    FDA Recall Open, Classified

    Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

    Recall: Z-0583-2025 · Initiated November 16, 2024

    Recall

    Recall Number
    Z-0583-2025
    Event Number
    95810
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 16, 2024
    Posted
    December 3, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

    Reason

    Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

    Action

    Philips notified consignees on about 11/16/2024, via certified mail. Consignees were instructed to identify any affected units on hand, identify if those units contain the affected software version, complete and return the response form, and circulate the Urgent Field Safety Notice Letter to all users of the device. To protect the user and patient from the issue of Plan Box not Updated, remain vigilant and confirm table position during procedures. Press any of the Emergency STOP buttons to stop unintended patient table motion and follow safety instructions in Section 6 of the IFU: Working with Specialized Exams. To avoid the issue of Wrong Patient ID with Anonymous patient, the operator should verify the patient information loaded into the patient data field is correct before scanning and rename the Anonymous record with the patient s name at the time of the scan.

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.

    Quantity

    301 units