NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
This recall is currently active, issued December 1, 2023. It was issued by Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom.
- Recall Initiated
- September 13, 2022
- Posted
- December 1, 2023
- Recall Number
- Z-0453-2024
- Quantity
- 19
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Serial numbers: 2003, 2004, 2005, 2006, 2007, 2009, 2010, 2011, 2017, 2018, 2015, 2020, 2019, 2001, 2021, 2028, 2033, 2036, 2030, 2029.
Root Cause
Device Design
Action Taken
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.