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Class 2 Device Recall Eleganza 3 Hospital Bed |
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Date Initiated by Firm |
May 02, 2011 |
Date Posted |
June 03, 2011 |
Recall Status1 |
Terminated 3 on July 19, 2012 |
Recall Number |
Z-2411-2011 |
Recall Event ID |
58785 |
Product Classification |
Bed, hydraulic, adjustable hospital - Product Code FNK
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Product |
Eleganza 3 Hospital Bed
Intended use: AC Powered adjustable Hospital Bed |
Code Information |
Models: Eleganza 3 (1GZ17045 with Scale) or (1GZ07045 without Scale), Accesory: Mobi-lift handle (P/N D310105B) (Located towards the foot side of bed on both sides), Serial Numbers: 20100043034 to 20100043045 |
Recalling Firm/ Manufacturer |
Linet Americas Inc 10430 Harris Oak Blvd Ste A Charlotte NC 28269-7511
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Manufacturer Reason for Recall |
Linet has been made aware that there has been breakage of the Mobi-lift handle on a few beds which may cause failure during patient assist use.
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FDA Determined Cause 2 |
Device Design |
Action |
The firm, Linet America, notified US customers only via phone on May 5, 2011. A follow up "service advisory information" letter dated May 11, 2011 was sent to all customers. The letter described the product, problem and action to be taken. The customers were instructed to remind/retrain staff to ensure that the Mobi-lift handles are always in the stowed position during patient transport and after use, and complete and return the attached Inspection procedure for each affected Eleganza 3 bed via mail to: Linet Americas, 10420-R Harris Oaks Blvd., Charlotte, NC 28269 or fax to: 704-248-5655. Linet Americas will be receiving a supply of new Mobi-lift design and will begin the process of executing service calls to replace the Morbi-lift handles with the new design.
If you have any questions, contact the Director of Quality and Service Operations at 704-248-5650 or 980-406-6446. |
Quantity in Commerce |
1601 units |
Distribution |
Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada. |
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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