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Recall Observatory FDA recall evidence

Device product

NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176

Z-0453-2024

September 13, 2022

Class II

Product summary

Firm
Thor Photomedicine Ltd
Event
Event 93344
Status
Ongoing
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-0453-2024

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: 2003, 2004, 2005, 2006, 2007, 2009, 2010, 2011, 2017, 2018, 2015, 2020, 2019, 2001, 2021, 2028, 2033, 2036, 2030, 2029.

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.