Recall Z-0011-2015— Nemschoff Chairs, Inc.
Class II · Terminated
Class II FDA medical device recall by Nemschoff Chairs, Inc., initiated 2011-01-18, terminated 2015-07-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Nemschoff Chairs, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-01-18
- Terminated
- 2015-07-24
- Firm location
- Sheboygan, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.