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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 16, 2022 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.