Wonju-Si, KR · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | 1 | 2020-10-09 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-05-17 | Class II | Terminated | Z-2096-2021 | AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), funct… | — | In some cases the equipment fails to power up and/or key or button unresponsive or not working. |
| 2020-05-15 | Class II | Terminated | Z-2441-2020 | DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive … | — | Failures were found in the temperature measurement function while in the predict mode. |