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U.S. Department of Health and Human Services

Class 2 Device Recall NovoTHOR Whole Body Light Pod, Gen 3.0

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 Class 2 Device Recall NovoTHOR Whole Body Light Pod, Gen 3.0see related information
Date Initiated by FirmNovember 20, 2023
Date PostedFebruary 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0972-2024
Recall Event ID 93723
Product Classification Lamp, infrared, therapeutic heating - Product Code ILY
ProductNovoTHOR 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
FEI Number 3003899624
Recalling Firm/
Manufacturer		 THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom
For Additional Information Contact
1494-797100
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
FDA Determined
Cause 2		Component design/selection
ActionOn 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 Commerce61 (41 US; 20 OUS)
DistributionDomestic 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.
Total Product Life CycleTPLC Device Report
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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