Linet AVE 2 Birthing Bed Recalled for Power Cable Safety Issue
Linet Spol. S.r.o. is recalling 253 AVE 2 Birthing Beds because the power cable may break or fail, posing a risk of sparks or exposure to live conductors.
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 involves a risk of electrical shock or fire (spark/live conductor) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Linet Spol. S.r.o. is recalling 253 units of the AVE 2 Birthing Bed. The recall is due to a potential safety issue where the power cable may break at the bed connection or the orange insulation of the power cable may fail.
This failure could cause a possible spark or possible exposure to a live conductor. The affected devices have serial numbers ranging from 4PPB0091 through 4PPB626.
The recalled devices were distributed in Alabama, Oklahoma, New Jersey, Oregon, Washington, California, Minnesota, Louisiana, Arizona, Illinois, Missouri, Colorado, Ohio, Kentucky, Florida, Kansas, Utah, Tennessee, and Texas. Consumers should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- AVE 2 Birthing Bed
- Manufacturer
- Linet Spol. S.r.o.
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 253
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 (1)
- Serial Numbers 4PPB0091 through 4PPB626
Distribution
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