Skip to content
Recall Observatory FDA recall evidence

Device product

NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183

Z-0455-2024

September 13, 2022

Class II

Product summary

Firm
Thor Photomedicine Ltd
Event
Event 93344
Status
Ongoing
Classification
Class II
Quantity
26
Official record key
device-enforcement:Z-0455-2024

Official wording

Reason: Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

Code information: Serial numbers: 2002, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2057, 2059, 2060, 2061, 2062, 2064, 2065, 2066, 2075, 2076, 2077, 2078, 2081, 2084, 2085, 2086, 2088, 2089, 2090, 2094, 2097.

Distribution pattern: Worldwide Distribution: US (Nationwide): Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, North Carolina, Ohio, Oregon, Texas, Utah, Virginia, West Virginia. OUS (foreign) to countries of: Australia, Canada, Netherlands, New Zealand, Singapore, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.