Class II — Mediana Co., Ltd.
| Recalling firm | MEDIANA CO., LTD. |
|---|---|
| Registered facility | MEDIANA CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | In some cases the equipment fails to power up and/or key or button unresponsive or not working. |
| Product | 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. |
| Quantity | 618 |
| Distribution | US Distribution to: Wisconsin only |
| Initiated | 2021-05-17 |
| Classified | 2021-07-19 |
| Terminated | 2022-11-04 |
| Recall number | Z-2096-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mediana Co., Ltd. (Z-2096-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88166/
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