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Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE51...

FDA Device Recall #Z-0767-2021 — Class II — November 13, 2019

Recall Summary

Recall Number Z-0767-2021
Classification Class II — Moderate risk
Date Initiated November 13, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Linet Spol. S.r.o.
Location Slany
Product Type Devices
Quantity 518 units

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.

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

a) 1GE512055-40: 20170042941, 20170042942, 20170042943, 20170042944, 20170042945, 20170042946, 20170043764, 20170043765, 20170043766, 20170043767, 20170043768, 20170043769, 20170043770, 20170043771, 20170043772, 20170043773, 20170043774, 20170043775 b) 1GE512055-45: 20170055478, 20170055479, 20170055480, 20170055481, 20170055482, 20170055483, 20170055484, 20170055485, 20170055486, 20170055487, 20170055488, 20170055489, 20170055490, 20170056038, 20170056039, 20170056040, 20170056041, 20170056042, 20170056043, 20170056044, 20170056045, 20170056046, 20170056047, 20170056048, 20170056049, 20170056050, 20170056051, 20170056052, 20170056053, 20170056054, 20170056055, 20170056056, 20170056527, 20170056528, 20170056529, 20170056530, 20170056531, 20170056532, 20170056533, 20170056534, 20170056535, 20170056536, 20170056537, 20170056538, 20170056539, 20170056540, 20170056541, 20170056542, 20170056543, 20170056544, 20170056545, 20170056546, 20170058170, 20170058171, 20170058172, 20170058173, 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Other Recalls from Linet Spol. S.r.o.

Recall # Classification Product Date
Z-1211-2023 Class II Sprint 200 wheeled stretcher, Item numbers 1ES2... Jan 18, 2023
Z-0991-2019 Class II AVE 2 Birthing Bed Jan 7, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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