CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report

NovoTHOR Whole Body Light Pod, Gen 3.0 Product recalled

Thor Photomedicine is recalling NovoTHOR Whole Body Light Pod, Gen 3.0, distributed in 17 states. The recall was initiated on 20 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(1) UDI-DI 05060494130503 Serial 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 (2) UDI-DI 05060494130527 Serial Number 4068 (3) UDI-DI 05060494130510 Serial Numbers 4002 4003 4006 4010 4012 4027 4030 4040 4038 4023 4045 4051 4052 4060 4057 4064 4056 4069 4063 4070 4089 4014

Quantity recalled61 (41 US; 20 OUS)

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-0972-2024
FDA event ID: 93723
Recalling firm: Thor Photomedicine, Amersham
Classification: Class II
Status: Ongoing
Recall initiated: 20 Nov 2023
FDA classified: 1 Feb 2024
Reported: 7 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Nov 2023	Recall initiated by company
1 Feb 2024	Classified by FDA	+73 days
7 Feb 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL

Where it was distributed

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.

Arizona California Colorado Connecticut Florida Georgia Hawaii Idaho Indiana Maryland New Jersey New York Oregon Pennsylvania Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

(1) UDI-DI 05060494130503 Serial 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 (2) UDI-DI 05060494130527 Serial Number 4068 (3) UDI-DI 05060494130510 Serial Numbers 4002 4003 4006 4010 4012 4027 4030 4040 4038 4023 4045 4051 4052 4060 4057 4064 4056 4069 4063 4070 4089 4014

Where was it sold?

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 26 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
3 Sep 2025Device	CLASS II	Brand Name: Thor Product Name: NovoTHOR Model/Catalog Number: S2188 recalled	Thor Photomedicine	Temperature Abuse	Nationwide
3 Sep 2025Device	CLASS II	NovoTHOR Gen 3.0 Reg PRX recalled by THOR Photomedicine	Thor Photomedicine	Temperature Abuse	Nationwide
3 Sep 2025Device	CLASS II	NovoTHOR XL recalled by THOR Photomedicine	Thor Photomedicine	Temperature Abuse	Nationwide
3 Sep 2025Device	CLASS II	NovoTHOR Gen 3.0 Reg PRX recalled by THOR Photomedicine	Thor Photomedicine	Temperature Abuse	Nationwide
13 Dec 2023Device	CLASS II	NovoTHOR Gen whole body red light therapy bed recalled	Thor Photomedicine	Device Malfunction	Nationwide

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