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Class 3 Device Recall Joerns Easy Care bed |
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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
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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
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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 .
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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
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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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