Z-0456-2024 Class II Ongoing
FDA device recall Z-0456-2024 was initiated by Thor Photomedicine Ltd on September 13, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- September 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
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 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.
Code Information
Serial numbers: 3025, 3026, 3027, 3030, 3031, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3042, 3043, 3044, 3045, 3047, 3050, 3051, 3053.