Eleganza 5 — Class II medical device recall Z-0767-2021
Ongoing recall by Linet Spol. S.r.o., reported 2021-01-13, distributed nationwide. A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking
| Recall number | Z-0767-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Linet Spol. S.r.o., Slany, Czech Republic |
| Recall initiated | 2019-11-13 |
| Classified | 2021-01-04 |
| Reported by FDA | 2021-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 518 units |
| Reason classes | device malfunction |
Product
Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel.
Reason for recall
A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0767-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.