Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-
FDA device recall Z-0011-2015 · posted 2014-10-06 · Terminated
Recall details
- Recalling firm
- Nemschoff Chairs, Inc.
- 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 taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- INM
- Quantity affected
- 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
- Date initiated
- 2011-01-18
- Date posted
- 2014-10-06
- Date terminated
- 2015-07-24
- Location
- Sheboygan, WI
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