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U.S. Department of Health and Human Services

Class 2 Device Recall PR1000 Pivot Rehab Bed

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  Class 2 Device Recall PR1000 Pivot Rehab Bed see related information
Date Initiated by Firm July 25, 2018
Create Date September 17, 2018
Recall Status1 Terminated 3 on October 11, 2019
Recall Number Z-3183-2018
Recall Event ID 80832
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product PR1000 Pivot Rehab Bed AC powered adjustable bed.
Code Information ALL Pivot Rehab PR1000 Beds built between 12/01/2010 thru 12/22/2014 SN: PR 10001 build date 12/01/2010 thru PR 10255 build date 12/22/2014
Recalling Firm/
Manufacturer		 Med-Mizer, Inc.
80 Commerce Dr
Batesville IN 47006-6700
For Additional Information Contact Kyle Tekulve
812-932-2345
Manufacturer Reason
for Recall		 Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made
FDA Determined
Cause 2		 Device Design
Action Customers were contacted via telephone on 7/25/18 to notify them of the issue and to make them aware of the correction. Customers were then mailed a notification letter along with necessary parts.
Quantity in Commerce 230 units
Distribution The products were distributed to the following US states: AR, AZ, FL, GA, IA, ID, IL, IN, KY, ME, MI, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. The products were distributed to the following foreign countries: Canada, China, and Denmark.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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