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U.S. Department of Health and Human Services

Class 2 Device Recall NovoThor

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 Class 2 Device Recall NovoThorsee related information
Date Initiated by FirmSeptember 13, 2022
Date PostedDecember 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0456-2024
Recall Event ID 93344
Product Classification Lamp, infrared, therapeutic heating - Product Code ILY
ProductNovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
Code Information Serial numbers: 3025, 3026, 3027, 3030, 3031, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3042, 3043, 3044, 3045, 3047, 3050, 3051, 3053.
FEI Number 3003899624
Recalling Firm/
Manufacturer		 Thor Photomedicine Ltd
Watermeadow House
Chesham United Kingdom
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionThe "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.
Quantity in Commerce26
DistributionWorldwide Distribution: US (Nationwide): Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, North Carolina, Ohio, Oregon, Texas, Utah, Virginia, West Virginia. OUS (foreign) to countries of: Australia, Canada, Netherlands, New Zealand, Singapore, United Kingdom.
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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