PlainRecordsFDA · Medical device recall
NovoTHOR Gen 2.0 whole body red light therapy bed… and 3 more products
- Date
- Dec. 13, 2023
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Thor Photomedicine Ltd
- Reason
- Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
- Distribution pattern
- 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.
4 products in this recall
NovoTHOR Gen 2.0 whole body red light therapy bed…
- Product
- NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
- Quantity
- 19
- Codes and lots
- Serial numbers: 2003, 2004, 2005, 2006, 2007, 2009, 2010, 2011, 2017, 2018, 2015, 2020, 2019, 2001, 2021, 2028, 2033, 2036, 2030, 2029.
- Recall started
- Sept. 13, 2022
- Device type
- Lamp, Infrared, Therapeutic Heating
- Root cause (FDA)
- Device Design
- What the company told customers
- 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.
- Recall number
- Z-0453-2024
G041 Pod…
- Product
- G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
- Quantity
- 6
- Codes and lots
- Serial numbers: 3001, 3002, 3004, 3008, 3009, 3006, 3003.
- Recall started
- Sept. 13, 2022
- Device type
- Lamp, Infrared, Therapeutic Heating
- Root cause (FDA)
- Device Design
- What the company told customers
- 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.
- Recall number
- Z-0454-2024
NovoTHOR Gen 2.5 Regular whole body red light therapy bed…
- Product
- NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
- Quantity
- 26
- Codes and lots
- 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.
- Recall started
- Sept. 13, 2022
- Device type
- Lamp, Infrared, Therapeutic Heating
- Root cause (FDA)
- Device Design
- What the company told customers
- 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.
- Recall number
- Z-0455-2024
NovoTHOR Gen 2.5 XL whole body red light therapy bed…
- Product
- NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
- Quantity
- 26
- Codes and lots
- Serial numbers: 3025, 3026, 3027, 3030, 3031, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3042, 3043, 3044, 3045, 3047, 3050, 3051, 3053.
- Recall started
- Sept. 13, 2022
- Device type
- Lamp, Infrared, Therapeutic Heating
- Root cause (FDA)
- Device Design
- What the company told customers
- 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.
- Recall number
- Z-0456-2024
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0453-2024, Z-0454-2024, Z-0455-2024, Z-0456-2024. The agency record governs; check it and the company before acting.