Recall Z-0972-2024 ยท ILY Lamp, Infrared, Therapeutic Heating
THOR Photomedicine Ltd
NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
| Date | Feb 1, 2024 (initiated Nov 20, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Component design/selection |
| Action | On November 20, 2023, the firm notified customers via IMPORTANT MEDICAL DEVICE CORRECTION letters sent through email. A service agent representing THOR will contact customers within the next eight weeks to schedule the fitting of replacement ball studs at no cost to the customer. Customers who continue to use the NovoTHOR should be aware that it may potentially cause harm should the failure occur while users/patients are lifting or lowering the canopy. Customers should warn all users of potential risk, ensure someone is present to lift and lower the canopy, ensure the canopy is lifted and l |
| Quantity | 61 (41 US; 20 OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.