Recall record at a glance
| Official record | Z-0011-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Nemschoff Chairs, Inc. |
| Report date | Oct 15, 2014 |
| Recall initiation date | Jan 18, 2011 |
| Quantity | 1868 |
| Location | Sheboygan, WI, United States |
Official product description
Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Why the product was recalled
Nemschoff Chairs, Inc. is recalling various model of the Serenity Treatment Chair because of potential elevated temperatures in the seat and back lumbar areas of the chair.
Distribution information
Worldwide Distribution: USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL ,IN, KS, KY, MA, MD, MI, MN, MO, MN, MT, NC, ND,NE, BH, NJ NM, NV, NY, OH, OK, OR, PA, PE, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and the country of CANADA.
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: Visit.
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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