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Class 2 Device Recall AVE 2 Birthing Bed |
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| Date Initiated by Firm |
January 07, 2019 |
| Create Date |
March 09, 2019 |
| Recall Status1 |
Terminated 3 on May 31, 2023 |
| Recall Number |
Z-0991-2019 |
| Recall Event ID |
81927 |
| Product Classification |
Table, obstetrical, ac-powered (and accessories) - Product Code HDD
|
| Product |
AVE 2 Birthing Bed |
| Code Information |
Serial Numbers 4PPB0091 through 4PPB626 |
Recalling Firm/
Manufacturer |
Linet Spol. S.r.o.
Zelevcice 5
Slany Czech Republic
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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 |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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