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U.S. Department of Health and Human Services

Class 2 Device Recall Serenity Treatment Chair

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  Class 2 Device Recall Serenity Treatment Chair see related information
Date Initiated by Firm January 18, 2011
Date Posted October 06, 2014
Recall Status1 Terminated 3 on July 24, 2015
Recall Number Z-0011-2015
Recall Event ID 69092
Product Classification Chair, with casters - Product Code INM
Product 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.
Code Information Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12.
Recalling Firm/
Manufacturer		 Nemschoff Chairs, Inc.
909 N 8th St
2218 Julson Ct
Sheboygan WI 53081-4056
For Additional Information Contact Mark Sherman
920-459-1230 Ext. 230
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action The corrections have been performed via heat service kits being installed "on demand" to address heating element malfunctions starting on 1/18/2011. Consignee letter to all customers is pending HHE assessment.
Quantity in Commerce 1868
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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