FDAFDA · Food and drugs·Recall number Z-0011-2015
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.
Published October 15, 2014 · Recall initiated: January 18, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Nemschoff Chairs, Inc.
- Distributor
- 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.
- Lot
- Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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