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U.S. Department of Health and Human Services

Class 3 Device Recall Joerns Easy Care bed

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  Class 3 Device Recall Joerns Easy Care bed see related information
Date Initiated by Firm November 16, 2005
Date Posted August 25, 2006
Recall Status1 Terminated 3 on November 02, 2006
Recall Number Z-1411-06
Recall Event ID 35922
Product Classification Hospital Bed manual adjustment - Product Code FNJ
Product Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
Code Information Serial numbers: 100104, 100604, 101804, 101904, 102004, 102204, 102504, 102604, 102704, 102904, 120804
Recalling Firm/
Manufacturer
Sunrise Medical CCG, Inc.
5501 Joerns Dr
Stevens Point WI 54481-5011
Manufacturer Reason
for Recall
Malfunction- the Easy care drive system performance, controlling back and knee section angle adjustment, as well as, bed height adjustment could become non-functional .
FDA Determined
Cause 2
Other
Action End-user facilities were contacted by Sunrise Medical Customer Service Team via telephone. All beds were inspected and corrected by factory-trained representatives or by affected locations'' facility engineers.
Quantity in Commerce 510
Distribution Nationwide distribution -including states of AZ, CA, CO, FL, IA, KY, MA, MO, MS, NC, ND, OH, OK, SC, TN, TX, VA, WI, and WV.
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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