BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

    Recall: Z-1858-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1858-2025
    Event ID
    96791
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    C-RAD POSITIONING AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 4, 2025
    Initiation Date
    April 22, 2025
    Classification Date
    May 28, 2025
    Address
    Bredgrand 18, N/A, Uppsala, N/A, N/A, Sweden

    Description

    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

    Reason

    Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

    Code Info

    All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024; Catalyst HD- SP001-0026/UDI: 07350005280024; Catalyst PT- SP001-0027/UDI: 07350005280024; Catalyst X4- SP002-0035/UDI: 07350005280024; Catalyst+ - REF: SP003-0001/UDI: 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793 Catalyst+ X4 - SP003-0009/UDI: 17350005280809

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.

    Quantity

    44 units