CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
NovoTHOR Gen whole body red light therapy bed recalled
Thor Photomedicine is recalling NovoTHOR Gen whole body red light therapy bed, distributed nationwide in the US. The recall was initiated on 13 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0456-2024
- FDA event ID
- 93344
- Recalling firm
- Thor Photomedicine, Chesham
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Sep 2022
- FDA classified
- 1 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Sep 2022 | Recall initiated by company | |
| 1 Dec 2023 | Classified by FDA | +444 days |
| 13 Dec 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoConnecticutFloridaHawaiiIowaIdahoIllinoisMarylandMichiganMinnesotaMissouriNorth CarolinaNew HampshireNevadaOhioOregonTexasUtah
Questions about this recall
Is NovoTHOR Gen whole body red light therapy bed recalled?
Yes. Thor Photomedicine recalled NovoTHOR Gen whole body red light therapy bed on 13 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0456-2024.
Why was it recalled?
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Which lots are affected?
Serial numbers: 3025, 3026, 3027, 3030, 3031, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3042, 3043, 3044, 3045, 3047, 3050, 3051, 3053.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Thor Photomedicine
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Brand Name: Thor Product Name: NovoTHOR Model/Catalog Number: S2188 recalled | THOR Photomedicine | Temperature Abuse | Nationwide |
| Device | CLASS II | NovoTHOR Gen 0 Reg PRX recalled by THOR Photomedicine | THOR Photomedicine | Temperature Abuse | Nationwide |
| Device | CLASS II | NovoTHOR XL recalled by THOR Photomedicine | THOR Photomedicine | Temperature Abuse | Nationwide |
| Device | CLASS II | NovoTHOR Gen 0 Reg PRX recalled by THOR Photomedicine | THOR Photomedicine | Temperature Abuse | Nationwide |
| Device | CLASS II | NovoTHOR Whole Body Light Pod, Gen 0 Product recalled | THOR Photomedicine | Other | 17 states |
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