Z-2441-2020Class II

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 -

Name: Z-2441-2020 DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 -
Creator: Mediana Co., Ltd.
Published: 2020-05-15
License: https://open.fda.gov/license/

Mediana Co., Ltd. / initiated 2020-05-15 / Terminated

FDA source

Mediana Co., Ltd. began a recall of DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional... on 2020-05-15. FDA classified it as Class II and gives the reason as "Failures were found in the temperature measurement function while in the predict mode". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2441-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-15
Posted: 2020-06-26
Terminated: 2022-09-16
Recalling firm: Mediana Co., Ltd.
Product: 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.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: Failures were found in the temperature measurement function while in the predict mode.
FDA root cause: Process change control
Action: The firm notified their sole consignee on 05/15/2020 by email. The device is being recalled to the user level.
Quantity in commerce: 180 devices
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: 456802000001~456802000180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2441-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2441-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

Product code DXN

K170497Class IIV10Mediana Co., Ltd. / cleared 2017-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)