Recall Z-2096-2021 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Mediana Co., Ltd.
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.
| Date | May 17, 2021 |
| Status | Terminated |
| Reason | In some cases the equipment fails to power up and/or key or button unresponsive or not working. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent a "URGENT : Field Safety Notice(Correction)" email dated May 17, 2021 to its consignee. The email describes the product, problem and actions to be taken. The following actions were to be implemented: Implementation of action plan (1) Inventory stock a importer's hand: Mediana service engineer will update before ship to end users. (2) The products at end user's hand: Provide the modified new Software via USB memory stick and instruction for upgrading the S/W 3. Required actions for the user - INSPECT the inventory for the affected Model number, serial number(s), and date of manuf |
| Quantity | 618 |
| Distribution | US Distribution to: Wisconsin only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200434 | V20, V20a, AVSM3 SNF Mediana Co., Ltd., Oct 9, 2020 |