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.
Reported: July 8, 2020 Initiated: May 15, 2020 #Z-2441-2020
Product Description
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.
Reason for Recall
Failures were found in the temperature measurement function while in the predict mode.
Details
- Recalling Firm
- Mediana Co., Ltd.
- Units Affected
- 180 devices
- Distribution
- US Nationwide distribution.
- Location
- Wonju, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mediana Co., Ltd.. Units affected: 180 devices.
Why was this product recalled? ▼
Failures were found in the temperature measurement function while in the predict mode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2441-2020.
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