Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed
FDA Recall Z-2411-2011 · Posted 2011-06-03
Recalling FirmLinet Americas Inc
Recall StatusTerminated
Product CodeFNK
Date Initiated2011-05-02
Date Terminated2012-07-19
Product Quantity1601 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.