Z-0991-2019Class II

AVE 2 Birthing Bed

Name: Z-0991-2019 AVE 2 Birthing Bed
Creator: Linet Spol. S.r.o.
Published: 2019-01-07
License: https://open.fda.gov/license/

LINET spol. s r.o. / initiated 2019-01-07 / Terminated / root cause: design

FDA source

Linet Spol. S.r.o. began a recall of AVE 2 Birthing Bed on 2019-01-07. FDA classified it as Class II and gives the reason as "LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0991-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-07
Posted: 2019-03-09
Terminated: 2023-05-31
Recalling firm: LINET spol. s r.o.
Product: AVE 2 Birthing Bed
Product code: HDD Table, Obstetrical, Ac-Powered (And Accessories)
Reason for recall: LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.
Root cause tag: design
FDA root cause: Device Design
Action: The firm disseminated their urgent correction notices on 01/07/2019 by mail. The notice discussed the potential safety issue and requested the consignee cease use of the bed if there was damage to the power cable. The firm will be providing a kit that includes a power cable hook and updated instruction for use.
Quantity in commerce: 253 devices
Distribution: AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX
Product codes and lots: Serial Numbers 4PPB0091 through 4PPB626

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0991-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0991-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-08

Product code HDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)