Device product
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Z-0453-2024
Product summary
- 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
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.