Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed

FDA device recall Z-2411-2011 · posted 2011-06-03 · Terminated

Recall details

Recalling firm

Linet Americas Inc

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.

Action taken

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

Status

Terminated

Product code

FNK

Quantity affected

1601 units

Distribution

Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.

Date initiated

2011-05-02

Date posted

2011-06-03

Date terminated

2012-07-19

Location

Charlotte, NC