Recall Z-0767-2021 ยท FNL Bed, Ac-Powered Adjustable Hospital
Linet Spol. S.r.o.
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.
| Date | Nov 13, 2019 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | The firm initiated the recall by email and hand delivery on 11/13/2019. The notice explains the malfunction and risk, and provides the following information: "Advice on action to be taken by the user: Linet has developed a correction for the side rail mechanism. We will contact you to schedule a Linet or partner technician to update your affected Eleganza 5 Beds with this correction. Until your affected beds are updated, we ask that you follow the safety information as outlined in the Eleganza 5 User manual (D9U001GE5-0101, version: 11, Publication date: 2019-11 (available at your local dist |
| Quantity | 518 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.