Z-0453-2024Class II

NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176

Name: Z-0453-2024 NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Creator: Thor Photomedicine Ltd
Published: 2022-09-13
License: https://open.fda.gov/license/

Thor Photomedicine Inc. / initiated 2022-09-13 / Open, Classified / root cause: design

FDA source

Thor Photomedicine Ltd began a recall of NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 on 2022-09-13. FDA classified it as Class II and gives the reason as "Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift". 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-0453-2024
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-13
Posted: 2023-12-01
Recalling firm: Thor Photomedicine Inc.
Product: NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Product code: ILY Lamp, Infrared, Therapeutic Heating
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.
Root cause tag: design
FDA root cause: Device Design
Action: The "IMPORTANT MEDICAL DEVICE CORRECTION" notification issued October 05, 2023 by email with follow-up phone call. The notice advises users (1) how to recognize the issue. (2) THOR is replacing all ball studs on all affected devices. Should you continue to have users/patients use the NovoTHOR, then be aware it may potentially cause harm should the failure occur whilst they are lifting or lowering the canopy. " Ensure you warn all users of the potential risk " Ensure someone is present to lift and lower the canopy " Ensure the canopy is lifted and lowered gently and slowly " Ensure someone is present in the room or immediately outside the room during use. A service representative will contact customers within 6 weeks to schedule correction. Customers are requested to respond to the email notice with their acknowledgement. Contact phone number for Thor is (877) 355 3151.
Quantity in commerce: 19
Distribution: 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.
Product codes and lots: Serial numbers: 2003, 2004, 2005, 2006, 2007, 2009, 2010, 2011, 2017, 2018, 2015, 2020, 2019, 2001, 2021, 2028, 2033, 2036, 2030, 2029.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0453-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0453-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0454-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0455-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0456-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

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)