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

FDA device recall Z-0453-2024 · posted 2023-12-01 · Open, Classified

Recall details

Recalling firm

Thor Photomedicine Ltd

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

ILY

Quantity affected

19

Distribution

Worldwide Distribution: US (Nationwide): Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, North Carol

Date initiated

2022-09-13

Date posted

2023-12-01

Location

Chesham, United Kingdom