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 | Failures were found in the temperature measurement function while in the predict mode. |
| Product | 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. |
| Quantity | 180 devices |
| Distribution | US Nationwide distribution. |
| Initiated | 2020-05-15 |
| Classified | 2020-06-26 |
| Terminated | 2022-09-16 |
| Recall number | Z-2441-2020 |
| 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-2441-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85685/
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