Linet Americas
Charlotte, NC, US
LINET AMERICAS appears in FDA device records in Charlotte, NC. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008007426 | 3008007426 | LINET AMERICAS | 9115 Harris Corners Pkwy Ste 150, Charlotte, NC 28269 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2781-2020 | AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed. | The UDI on the device label indicates incorrect manufacturer. | Class III | Open, Classified | |
| Z-0738-2012 | 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. | The premature failure of the Remote Handset buttons may result in unintended movement of the bed. | Terminated | ||
| Z-2411-2011 | Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain