CLASS II Device recall · Reported 28 Jul 2021 · FDA Enforcement Report
AVSM3 SNF, Vital Signs Monitor The monitor is intended to recalled
Mediana Co is recalling AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive, distributed in Wisconsin. The recall was initiated on 17 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2096-2021
- FDA event ID
- 88166
- Recalling firm
- Mediana Co, Wonju, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2021
- FDA classified
- 19 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Patient Monitors
Timeline
| 17 May 2021 | Recall initiated by company | |
| 19 Jul 2021 | Classified by FDA | +63 days |
| 28 Jul 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to: Wisconsin only
Questions about this recall
Is AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive recalled?
Yes. Mediana Co recalled AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive on 17 May 2021. The recall is Class II and its status is Terminated. Recall number Z-2096-2021.
Why was it recalled?
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Which lots are affected?
Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066
Where was it sold?
US Distribution to: Wisconsin only
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mediana Co
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direct Supply Attendant Vital Signs Monitor recalled by Mediana Co | Mediana Co | Temperature Abuse | Nationwide |
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |