Recall Z-0972-2024— THOR Photomedicine Ltd
Class II · Ongoing
Class II FDA medical device recall by THOR Photomedicine Ltd, initiated 2023-11-20. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- THOR Photomedicine Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-20
- Firm location
- Amersham, United Kingdom
Product description
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 for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.