FDA Medical Device Recalls (openFDA)
Thor Photomedicine Ltd: NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
- Recall number
- Z-0455-2024
- Recalling firm
- Thor Photomedicine Ltd
- Product
- NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
- Status
- Open, Classified
- Initiated
- 2022-09-13
- Posted
- 2023-12-01
- Terminated
- not on file
- Reason
- Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Serial numbers: 2002, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2057, 2059, 2060, 2061, 2062, 2064, 2065, 2066, 2075, 2076, 2077, 2078, 2081, 2084, 2085, 2086, 2088, 2089, 2090, 2094, 2097.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ILY
- Firm FEI
- 3003899624
- Firm city
- Chesham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28