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U.S. Department of Health and Human Services

Class 2 Device Recall Eleganza 3 Hospital Bed

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 Class 2 Recall
Eleganza 3 Hospital Bed
see related information
Date Posted June 03, 2011
Recall Status1 Terminated on July 19, 2012
Recall Number Z-2411-2011
Recall Event ID 58785
Product Classification Bed, Hydraulic, Adjustable Hospital - Product Code FNK
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, North Carolina 28269-7511
Consumer Instructions Contact the recalling firm for information
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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