Wonju, N/A, Korea (the Republic of)
Mediana Co., Ltd. recalls
2 recalls recorded since 2018, most recently on 17 May 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 17 May 2021
- Terminated
- 4 November 2022
- Reason
- In some cases the equipment fails to power up and/or key or button unresponsive or not working.
- Distribution
- US Distribution to: Wisconsin only
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2096-2021
- 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 an
Terminated Class II Medical devices
- Recall started
- 15 May 2020
- Terminated
- 16 September 2022
- Reason
- Failures were found in the temperature measurement function while in the predict mode.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2441-2020
- 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 (T
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.