Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoT

FDA device recall Z-2416-2025 · posted 2025-08-22 · Open, Classified

Recall details

Recalling firm

THOR Photomedicine Ltd

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

ILY

Quantity affected

80 units (66 US, 14 OUS)

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

Date initiated

2025-07-24

Date posted

2025-08-22

Location

Amersham, United Kingdom