BEUDAMED
    FDA Enforcement Class II Ongoing

    Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

    Recall: Z-1584-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1584-2023
    Event ID
    92064
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2023
    Initiation Date
    March 17, 2023
    Classification Date
    May 12, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

    Reason

    Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

    Code Info

    UDI-DI: 00884838101111; Serial Numbers: 10058 10074 10080 10093 10096 10097 10098 10099 10100 10102 10103 10104 10105 10106 10107 10109 10110 10111 10114 10115 10117 10119 10123 396001 396003 10014 10015 10016 10017 10018 10019 10020 10021 10022 10023 10024 10025 10027 10031 10032 10033 10034 10035 10036 10038 10039 10040 10041 10042 10043 10044 10045 10046 10047 10048 10050 10051 10052 10053 10055 10056 10057 10059 10060 10061 10062 10063 10065 10066 10067 10068 10069 10070 10075 10076 10077 10081 10082 10085 10086 10087 10089 10090 10092 10094 10095 10108 10116 10120 10049 10121 10124

    Distribution

    Worldwide - US Nationwide distribution including in the states of States: AZ, IN, MA, MD, MN, NY, OH, PA, and TX. The countries of Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Thailand, United Kingdom.

    Quantity

    92 units