FDA Medical Device Recalls (openFDA)
Linet Americas Inc: Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed
- Recall number
- Z-2411-2011
- Recalling firm
- Linet Americas Inc
- Product
- Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed
- Status
- Terminated
- Initiated
- 2011-05-02
- Posted
- 2011-06-03
- Terminated
- 2012-07-19
- Reason
- 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
- 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
- 1601 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNK
- Firm FEI
- 3008007426
- Firm city
- Charlotte
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28