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Class 2 Device Recall NovoTHOR Whole Body Light Pod, Gen 3.0 |
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Date Initiated by Firm |
November 20, 2023 |
Date Posted |
February 01, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0972-2024 |
Recall Event ID |
93723 |
Product Classification |
Lamp, infrared, therapeutic heating - Product Code ILY
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Product |
NovoTHOR Whole Body Light Pod, Gen 3.0
(1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL |
Code Information |
(1) UDI-DI 05060494130503
Serial Numbers
4004
4009
4013
4017
4019
4021
4024
4026
4028
4029
4035
4037
4042
4043
4044
4046
4047
4048
4054
4065
4066
4072
4073
4074
4076
4077
4078
4079
4080
4081
4082
4083
4085
4086
4087
4090
4091
4096
(2) UDI-DI 05060494130527
Serial Number 4068
(3) UDI-DI 05060494130510
Serial Numbers
4002
4003
4006
4010
4012
4027
4030
4040
4038
4023
4045
4051
4052
4060
4057
4064
4056
4069
4063
4070
4089
4014
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Recalling Firm/ Manufacturer |
THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom
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For Additional Information Contact |
1494-797100
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Manufacturer 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
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FDA Determined Cause 2 |
Component design/selection |
Action |
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. |
Quantity in Commerce |
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 distribution to Australia, Canada, Italy, Malta, Norway, Switzerland, UAE, and UK.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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