BEUDAMED
    FDA Enforcement Class II Ongoing

    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL

    Recall: Z-0972-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0972-2024
    Event ID
    93723
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    THOR Photomedicine Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2024
    Initiation Date
    November 20, 2023
    Classification Date
    February 1, 2024
    Address
    2 Anglo Office Park, Units 1 &; 67 White Lion Road, Amersham, N/A, United Kingdom

    Description

    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL

    Reason

    One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy

    Code Info

    (1) UDI-DI 05060494130503 Serial Numbers 4004 4009 4013 4017 4019 4021 4024 4026 4028 4029 4035 4037 4042 4043 4044 4046 4047 4048 4054 4065 4066 4072 4073 4074 4076 4077 4078 4079 4080 4081 4082 4083 4085 4086 4087 4090 4091 4096 (2) UDI-DI 05060494130527 Serial Number 4068 (3) UDI-DI 05060494130510 Serial Numbers 4002 4003 4006 4010 4012 4027 4030 4040 4038 4023 4045 4051 4052 4060 4057 4064 4056 4069 4063 4070 4089 4014

    Distribution

    Domestic distribution to the states of Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Indiana Maryland New Jersey New York Oregon Pennsylvania Texas Washington Wisconsin. Foreign distribution to Australia, Canada, Italy, Malta, Norway, Switzerland, UAE, and UK.

    Quantity

    61 (41 US; 20 OUS)