NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Summary
The FDA issued a Class II for NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183 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..
Details
Source
Device Recall
External ID
Z-0455-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Lot/Code Info: 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.
Quantity Affected: 26
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-13
Company
Chesham
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Thor Photomedicine Ltd has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Thor Photomedicine Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Thor Photomedicine Ltd have FDA actions?
Thor Photomedicine Ltd has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0455-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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