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Class 2 Device Recall NovoThor |
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Date Initiated by Firm |
September 13, 2022 |
Date Posted |
December 01, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0456-2024 |
Recall Event ID |
93344 |
Product Classification |
Lamp, infrared, therapeutic heating - Product Code ILY
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Product |
NovoTHOR 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. |
Recalling Firm/ Manufacturer |
Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom
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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.
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FDA Determined Cause 2 |
Device Design |
Action |
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. |
Quantity in Commerce |
26 |
Distribution |
Worldwide 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.
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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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