Z-2096-2021 Class II Terminated
FDA device recall Z-2096-2021 was initiated by Mediana Co., Ltd. on May 17, 2021 and is designated Class II. Reason for recall: In some cases the equipment fails to power up and/or key or button unresponsive or not working. The recall status is terminated (terminated November 4, 2022). Affected quantity: 618.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- May 17, 2021
- Termination Date
- November 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 618
Product Description
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Reason for Recall
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Distribution Pattern
US Distribution to: Wisconsin only
Code Information
Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066