Events

Recall of Device Recall Serenity Treatment Chair

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nemschoff Chairs, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69092
  • Event Risk Class
    Class 2
  • Event Number
    Z-0011-2015
  • Event Initiated Date
    2011-01-18
  • Event Date Posted
    2014-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129616
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Chair, with casters - Product Code INM
  • 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.

Device

Device Recall Serenity Treatment Chair
  • Model / Serial
    Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • 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.
  • Manufacturer
    Nemschoff Chairs, Inc.

Manufacturer

Nemschoff Chairs, Inc.
  • Manufacturer Address
    Nemschoff Chairs, Inc., 909 N 8th St, 2218 Julson Ct, Sheboygan WI 53081-4056
  • Source
    USFDA