Linet Eleganza 5 Adjustable Bed Recalled for Side Rail Malfunction
Linet Spol. S.r.o. is recalling 518 Eleganza 5 adjustable beds because a side rail component may malfunction, causing the rail to fail to lock or become stuck in the upper position.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a safety feature (side rail) on a medical device used in intensive care, which poses a risk of harm to patients, although no specific injuries are reported in the source text.
Plain-English summary
Linet Spol. S.r.o. is recalling 518 units of the Eleganza 5 AC powered adjustable bed. The affected item numbers are 1GE512055-40, 1GE512055-45, 1GE512055-85, and 1GE512055-95. These beds are designed for intensive care settings to support patients and facilitate treatment and manipulation by nursing personnel.
The recall is due to a potential malfunction in a component used within the side rail mechanism. This defect may result in the side rail either not locking properly in the upper position or becoming stuck in the upper position. The FDA has classified this as a Class II recall.
The affected units were distributed nationwide in the United States. No specific dates or additional distribution details are provided in the source text. Healthcare facilities and consumers should check their inventory for the specific item numbers and serial codes listed in the official recall notice to determine if they are affected.
The recalled product
- 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…
- Manufacturer
- Linet Spol. S.r.o.
- Category
- Medical Device — Hospital Bed
- Affected units
- 518
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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