Z-2418-2025Class II

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A...

Name: Z-2418-2025 Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A...
Creator: THOR Photomedicine Ltd
Published: 2025-07-24
License: https://open.fda.gov/license/

Thor Photomedicine Inc. / initiated 2025-07-24 / Open, Classified / root cause: manufacturing process

FDA source

THOR Photomedicine Ltd began a recall of Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are... on 2025-07-24. FDA classified it as Class II and gives the reason as "The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached 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 manufacturing process.

Recall record

Recall number: Z-2418-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-24
Posted: 2025-08-22
Recalling firm: Thor Photomedicine Inc.
Product: Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A
Product code: ILY Lamp, Infrared, Therapeutic Heating
Reason for recall: The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On July 24, 2025, IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions by THOR: A service agent representing THOR will contact you within the next 10 weeks to schedule the fitting of the four high tensile strength steel bolts to the inside of the chassis. The process is likely to take around 3 hours and, of course, there is no fee. Required Actions for NovoTHOR Owners: 1. Please reply to this email within four days to acknowledge your receipt and understanding of this notification. 2. If you no longer own the NovoTHOR, please forward this notice to the new owner if the device was sold and reply to this email with the contact details of the new owner. Other Actions for Owners: 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. THOR Contact Information: Call +44 (0)1494 797 100, Monday through Friday, 5:00 AM to 2:00 PM, Eastern Time or via thorlaser.com/contact.htm.
Quantity in commerce: 1 unit
Distribution: Worldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV; and OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.
Product codes and lots: Model/Catalog Number: S2189; UDI-DI: 05060494130480; Only one device of this type is in scope. Serial number: 4068;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2418-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2416-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-22
Z-2417-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-22
Z-2418-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-22
Z-2419-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-22

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)