FDA Medical Device Recalls (openFDA)
Linet Americas Inc: Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.
- Recall number
- Z-0738-2012
- Recalling firm
- Linet Americas Inc
- Product
- Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.
- Status
- Terminated
- Initiated
- 2011-12-08
- Posted
- 2012-01-13
- Terminated
- 2012-07-20
- Reason
- The premature failure of the Remote Handset buttons may result in unintended movement of the bed.
- Root cause
- Nonconforming Material/Component
- Action
- Linet sent a notification letter dated December 9, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken. The letter states that firm Linet has decided to do a voluntary field correction to replace the recalled product. The replacement will be completed by the territory Representative (Linet Employee) who will replace the affected product for each customer personally. The replacement takes approximately 30 seconds and does not require the patient to be moved. For questions or concerns call 704-248-5650.
- Quantity
- 29,252 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AL, FL, KY, LA, MA, NC, NY, OH and the country of: Canada
- Lot, serial or model codes
- Model numbers: 1GZ, 1GV, IS, 1GM, 1AG, 1MC and 1L.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- 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