Recall Z-0454-2024 ยท ILY Lamp, Infrared, Therapeutic Heating
Thor Photomedicine Ltd
G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
| Date | Dec 1, 2023 (initiated Sep 13, 2022) |
| Status | Open, Classified |
| Reason | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. |
| Root cause | Device Design |
| Action | The "IMPORTANT MEDICAL DEVICE CORRECTION" notification issued October 05, 2023 by email with follow-up phone call. The notice advises users (1) how to recognize the issue. (2) THOR is replacing all ball studs on all affected devices. Should you continue to have users/patients use the NovoTHOR, then be aware it may potentially cause harm should the failure occur whilst they are lifting or lowering the canopy. " Ensure you warn all users of the potential risk " Ensure someone is present to lift and lower the canopy " Ensure the canopy is lifted and lowered gently and slowly " Ensure someo |
| Quantity | 6 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.