FDA recall Z-0453-2024

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2022-09-13

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesham, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0453-2024