Recall Z-0767-2021— Linet Spol. S.r.o.
Class II · Ongoing
Class II FDA medical device recall by Linet Spol. S.r.o., initiated 2019-11-13. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Linet Spol. S.r.o.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-11-13
- Firm location
- Slany, Czech Republic
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.