FDA Medical Device Recalls (openFDA)
Linet Spol. S.r.o.: AVE 2 Birthing Bed
- Recall number
- Z-0991-2019
- Recalling firm
- Linet Spol. S.r.o.
- Product
- AVE 2 Birthing Bed
- Status
- Terminated
- Initiated
- 2019-01-07
- Posted
- not on file
- Terminated
- 2023-05-31
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Serial Numbers 4PPB0091 through 4PPB626
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HDD
- Firm FEI
- 3008058231
- Firm city
- Slany
- Firm state
- not on file
- Firm country
- Czech Republic
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28