Recall Z-2441-2020 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Mediana Co., Ltd.
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor 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.
| Date | May 15, 2020 |
| Status | Terminated |
| Reason | Failures were found in the temperature measurement function while in the predict mode. |
| Root cause | Process change control |
| Action | The firm notified their sole consignee on 05/15/2020 by email. The device is being recalled to the user level. |
| Quantity | 180 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170497 | V10 Mediana Co., Ltd., Dec 15, 2017 |