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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

THOR Photomedicine Ltd: NovoTHOR Whole Body Light Pods Recalled Due to Potential Canopy Failure

Agency Publication Date: February 1, 2024
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Summary

THOR Photomedicine Ltd is recalling 61 NovoTHOR Whole Body Light Pods (Generation 3.0) because a ball stud attaching the gas strut to the canopy may fail. If this component breaks, the heavy canopy may not stay open or could fall unexpectedly while a person is entering or exiting the pod. This recall affects three specific models: the Regular, Regular PRX, and XL versions manufactured in the United Kingdom and distributed globally.

Risk

The failure of the ball stud can cause the canopy to collapse or fail to remain in an open position, posing a risk of impact or crushing injuries to anyone inside or near the pod while attempting to open or close it.

What You Should Do

  1. Check your NovoTHOR Whole Body Light Pod to determine if it is a Generation 3.0 model and locate the serial number and UDI-DI on the device labeling.
  2. Verify if your serial number is included in this recall: For Product Code S2188 (Reg), affected numbers include 4004, 4009, 4013, 4017, 4019, 4021, 4024, 4026, 4028, 4029, 4035, 4037, 4042, 4043, 4044, 4046, 4047, 4048, 4054, 4065, 4066, 4072, 4073, 4074, 4076, 4077, 4078, 4079, 4080, 4081, 4082, 4083, 4085, 4086, 4087, 4090, 4091, 4096.
  3. Check for serial number 4068 if you own Product Code S2189 (Reg PRX), or serial numbers 4002, 4003, 4006, 4010, 4012, 4027, 4030, 4040, 4038, 4023, 4045, 4051, 4052, 4060, 4057, 4064, 4056, 4069, 4063, 4070, 4089, 4014 if you own Product Code S2190 (XL).
  4. Contact THOR Photomedicine Ltd or your healthcare provider immediately for further instructions regarding the inspection or repair of the canopy ball studs.
  5. If you experience any resistance or unusual noise when opening or closing the canopy, exercise extreme caution and contact the manufacturer before further use.
  6. For additional questions or to report an issue, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall via notification letter.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NovoTHOR Whole Body Light Pod, Gen 3.0 (Reg)
Model / REF:
S2188
UPC Codes:
05060494130503
Lot Numbers:
4004
4009
4013
4017
4019
4021
4024
4026
4028
4029
4035
4037
4042
4043
4044
4046
4047
4048
4054
4065
4066
4072
4073
4074
4076
4077
4078
4079
4080
4081
4082
4083
4085
4086
4087
4090
4091
4096
Product: NovoTHOR Whole Body Light Pod, Gen 3.0 (Reg PRX)
Model / REF:
S2189
UPC Codes:
05060494130527
Lot Numbers:
4068
Product: NovoTHOR Whole Body Light Pod, Gen 3.0 (XL)
Model / REF:
S2190
UPC Codes:
05060494130510
Lot Numbers:
4002
4003
4006
4010
4012
4027
4030
4040
4038
4023
4045
4051
4052
4060
4057
4064
4056
4069
4063
4070
4089
4014

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93723
Status: Active
Manufacturer: THOR Photomedicine Ltd
Sold By: Specialty medical distributors; THOR Photomedicine Ltd
Manufactured In: United Kingdom
Units Affected: 61 (41 US; 20 OUS)
Distributed To: Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Maryland, New Jersey, New York, Oregon, Pennsylvania, Texas, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.