Recall record at a glance
| Official record | Z-1177-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | ProSun International, LLC |
| Report date | Apr 24, 2019 |
| Recall initiation date | Dec 10, 2018 |
| Quantity | 250 devices of which 9 are affected |
| Location | Saint Petersburg, FL, United States |
Official product description
ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROSUN V3 42 HIGH INTENSIVE (160W) RED, PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE TMAX READY
Why the product was recalled
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Distribution information
US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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