Recall Z-0991-2019— Linet Spol. S.r.o.
Class II · Terminated
Class II FDA medical device recall by Linet Spol. S.r.o., initiated 2019-01-07, terminated 2023-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: AVE 2 Birthing Bed. 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..
- Recalling firm
- Linet Spol. S.r.o.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-07
- Terminated
- 2023-05-31
- Firm location
- Slany, N/A, Czech Republic
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.