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Terminated

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.

FDA Recall Z-2441-2020 · Posted None

Recalling FirmMediana Co., Ltd.
Recall StatusTerminated
Product CodeDXN
Date Initiated2020-05-15
Date Terminated2022-09-16
Product Quantity180 devices

Reason for Recall

Failures were found in the temperature measurement function while in the predict mode.

Firm Action

The firm notified their sole consignee on 05/15/2020 by email. The device is being recalled to the user level.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170497V10Mediana Co., Ltd. · 2017-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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