THOR PHOTOMEDICINE INC.
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
Devices registered here (1)
- Lamp, Infrared, Therapeutic HeatingProduct code ILY (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5500
Recalls & enforcement
- Class IIOngoing2025-07-24The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
- Class IIOngoing2023-11-20One 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
- Class IIOngoing2022-09-13Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “THOR PHOTOMEDICINE INC. (FEI 3034745472) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3034745472-thor-photomedicine-inc/
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