FDA Recall Terminated

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.

Recall: Z-0011-2015 · Initiated January 18, 2011

Recall

Recall Number
Z-0011-2015
Event Number
69092
Firm
Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056
FEI Number
3001591966
Product Code
INM
Status
Terminated
Root Cause
Device Design
Initiated
January 18, 2011
Posted
October 6, 2014
Terminated
July 24, 2015

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.

Reason

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.

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.

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.

Quantity

1868