Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2411-2011

Eleganza 3 Hospital Bed

Linet Americas / initiated 2011-05-02 / Terminated / root cause: design

Linet Americas Inc began a recall of Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2411-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Linet Americas
Product
Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed
Product code
FNK Bed, Hydraulic, Adjustable Hospital
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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