BEUDAMED
    FDA Recall Open, Classified

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    Recall: Z-1660-2025 · Initiated April 1, 2025

    Recall

    Recall Number
    Z-1660-2025
    Event Number
    96667
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 1, 2025
    Posted
    April 23, 2025
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    Reason

    Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

    Action

    An "URGENT Medical Device Correction" Notice dated 4/1/25 was mailed to consignees. The notice instructs consignees on how to identify if their unit is affected by this recall. Consignees are instructed to continue use of affected devices by following the recommended actions outlined in the notice and Appendix A. Consignees are asked to return the completed URGENT Medical Device Correction Response Form within 30 days of notification of this recall event via email: [email protected]. The recall notification is to be circulated among users and retained near affected devices until the update is installed. Philips will be contacting consignees to schedule a Field Service Engineer to visit affected sites and install the update (FCO72800825). Consignees with any questions are to call the Customer Care Solutions Center at 1-800-722-9377.

    Distribution

    Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg, Mauritius, Mexico, Monaco, Morocco, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, R¿union, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, T¿rkiye, Turkmenistan, United Kingdom, UAE & Yemen.

    Quantity

    630 units