Z-2441-2020 Class II Terminated

Recalled by Mediana Co., Ltd. — Wonju, N/A

Recall Details

Product Type
Devices
Report Date
July 8, 2020
Initiation Date
May 15, 2020
Termination Date
September 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 devices

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.

Distribution Pattern

US Nationwide distribution.

Code Information

Serial Numbers: 456802000001~456802000180