FDA Device Recall Z-0011-2015: Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-2015.

Recall Res Number

Z-0011-2015

Recalling Firm / Manufacturer

Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056

FEI Number

3001591966

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-01-18

Date Posted

2014-10-06

Date Terminated

2015-07-24

Product Code

INM

Event Number

69092

Product Quantity

1868

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.

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.

Action Details 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 Pattern 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.

Code Information / Serial Numbers Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12.

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Medical Device Recall: Z-0011-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer