| | Class 3 Device Recall Joerns Easy Care bed |  |
| Date Initiated by Firm | November 16, 2005 |
| Date Posted | August 25, 2006 |
| Recall Status1 |
Terminated 3 on November 02, 2006 |
| Recall Number | Z-1412-06 |
| Recall Event ID |
35922 |
| Product Classification |
Hospital Bed powered adjustment - Product Code FNL
|
| Product | Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds |
| Code Information |
Models: B684 & B684DC -Serial numbers: 101204, 101804, 101904, 102004, 102104, 102204, 102504, 102604, 102804, 102904, 110104, 111204.---Model B694, Serial number: 113004. |
| FEI Number |
2182305
|
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 | 156 |
| 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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