Recall Z-0991-2019 ยท HDD Table, Obstetrical, Ac-Powered (And Accessories)
Linet Spol. S.r.o.
AVE 2 Birthing Bed
| Date | Jan 7, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.