Recall archive / FDA device enforcement
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code... — FDA record Z-0972-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
- Reason
- One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy
- Classification
- Class II
- Recalling firm
- THOR Photomedicine Ltd
- Quantity
- 61 (41 US; 20 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0972-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (1) UDI-DI 05060494130503 Serial Numbers 4004 4009 4013 4017 4019 4021 4024 4026 4028 4029 4035 4037 4042 4043 4044 4046 4047 4048 4054 4065 4066 4072 4073 4074 4076 4077 4078 4079 4080 4081 4082 4083 4085 4086 4087 4090 4091 4096 (2) UDI-DI 05060494130527 Serial Number 4068 (3) UDI-DI 05060494130510 Serial Numbers 4002 4003 4006 4010 4012 4027 4030 4040 4038 4023 4045 4051 4052 4060 4057 4064 4056 4069 4063 4070 4089 4014 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to the states of Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Indiana Maryland New Jersey New York Oregon Pennsylvania Texas Washington Wisconsin. Foreign distribution to Australia, Canada, Italy, Malta, Norway, Switzerland, UAE, and UK.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 7, 2024
- Recall initiation date
- Nov 20, 2023
- Center classification date
- Feb 1, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.