Drug recall
Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and…
FDA recall event 86647 · Class II · Linet Spol. S.r.o.
Key facts
| Event ID | 86647 |
|---|---|
| Recall numbers | Z-0767-2021 |
| Recalling firm | Linet Spol. S.r.o. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 13, 2019 |
| Report date | Jan 13, 2021 |
| City | Slany |
| Country | Czech Republic |
| FEI number | 3008058231 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: