G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
FDA Device Recall #Z-0454-2024 — Class II — September 13, 2022
Recall Summary
| Recall Number | Z-0454-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 13, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Thor Photomedicine Ltd |
| Location | Chesham |
| Product Type | Devices |
| Quantity | 6 |
Product Description
G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
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.
Lot / Code Information
Serial numbers: 3001, 3002, 3004, 3008, 3009, 3006, 3003.
Other Recalls from Thor Photomedicine Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2419-2025 | Class II | Brand Name: THOR Product Name: NovoTHOR Gen 3.... | Jul 24, 2025 |
| Z-2417-2025 | Class II | Brand Name: THOR Product Name: NovoTHOR XL Mo... | Jul 24, 2025 |
| Z-2418-2025 | Class II | Brand Name: THOR Product Name: NovoTHOR Gen 3.... | Jul 24, 2025 |
| Z-2416-2025 | Class II | Brand Name: THOR Product Name: NovoTHOR Model... | Jul 24, 2025 |
| Z-0972-2024 | Class II | NovoTHOR Whole Body Light Pod, Gen 3.0 (1) P... | Nov 20, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.