NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2

FDA device recall Z-0972-2024 · posted 2024-02-01 · Open, Classified

Recall details

Recalling firm

THOR Photomedicine Ltd

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

Action taken

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.

Root cause

Component design/selection

Status

Open, Classified

Product code

ILY

Quantity affected

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

Date initiated

2023-11-20

Date posted

2024-02-01

Location

Amersham, United Kingdom