Reported Jul 8, 2020 · Terminated
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive…
Mediana Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mediana Co., Ltd. · 132 Donghwagongdan-Ro · Wonju, N/A · N/A
Is this the product you have?
- DIRECT SUPPLY Attendant VITAL SIGNS MONITOR
- REF AVSM2 - Product UsageIt 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
- Lot codes and dates
- Serial Numbers456802000001~456802000180
- Amount recalled
- 180 devices
Where it was sold
- Nationwide
Why it was recalled
Failures were found in the temperature measurement function while in the predict mode.
This product could cause temporary or reversible health problems — stop using it.
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