Z-0972-2024Class II

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

Name: Z-0972-2024 NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3)...
Creator: THOR Photomedicine Ltd
Published: 2023-11-20
License: https://open.fda.gov/license/

Thor Photomedicine Inc. / initiated 2023-11-20 / Open, Classified / root cause: design

FDA source

THOR Photomedicine Ltd began a recall of NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL on 2023-11-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0972-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-20
Posted: 2024-02-01
Recalling firm: Thor Photomedicine Inc.
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
Product code: ILY Lamp, Infrared, Therapeutic Heating
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
Root cause tag: design
FDA root cause: Component design/selection
Action: On November 20, 2023, the firm notified customers via IMPORTANT MEDICAL DEVICE CORRECTION letters sent through email. A service agent representing THOR will contact customers within the next eight weeks to schedule the fitting of replacement ball studs at no cost to the customer. Customers who continue to use the NovoTHOR should be aware that it may potentially cause harm should the failure occur while users/patients are lifting or lowering the canopy. Customers should warn all users of potential risk, ensure someone is present to lift and lower the canopy, ensure the canopy is lifted and lowered gently and slowly, and ensure someone is present in the room or immediately outside the room during use.
Quantity in commerce: 61 (41 US; 20 OUS)
Distribution: 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.
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0972-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0972-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01

Product code ILY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)