FDA recall Z-0991-2019

Linet Spol. S.r.o. · Class II · device

Product

AVE 2 Birthing Bed

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.

Distribution

AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX

Key facts

Status
Terminated
Initiation date
2019-01-07
Report date
2019-03-20
Termination date
2023-05-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Slany, N/A, Czech Republic

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0991-2019