Z-0991-2019 Class II Terminated
FDA device recall Z-0991-2019 was initiated by Linet Spol. S.r.o. on January 7, 2019 and is designated Class II. 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 cau… The recall status is terminated (terminated May 31, 2023). Affected quantity: 253 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- January 7, 2019
- Termination Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 253 devices
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.
Distribution Pattern
AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX
Code Information
Serial Numbers 4PPB0091 through 4PPB626