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Class 2 Device Recall Serenity Treatment Chair |
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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
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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
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For Additional Information Contact |
Mark Sherman 920-459-1230 Ext. 230
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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.
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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
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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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