Z-2096-2021Class II

AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure...

Name: Z-2096-2021 AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure...
Creator: Mediana Co., Ltd.
Published: 2021-05-17
License: https://open.fda.gov/license/

Mediana Co., Ltd. / initiated 2021-05-17 / Terminated / root cause: manufacturing process

FDA source

Mediana Co., Ltd. began a recall of AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2)... on 2021-05-17. FDA classified it as Class II and gives the reason as "In some cases the equipment fails to power up and/or key or button unresponsive or not working". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2096-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-17
Posted: 2021-07-19
Terminated: 2022-11-04
Recalling firm: Mediana Co., Ltd.
Product: AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used 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: In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent a "URGENT : Field Safety Notice(Correction)" email dated May 17, 2021 to its consignee. The email describes the product, problem and actions to be taken. The following actions were to be implemented: Implementation of action plan (1) Inventory stock a importer's hand: Mediana service engineer will update before ship to end users. (2) The products at end user's hand: Provide the modified new Software via USB memory stick and instruction for upgrading the S/W 3. Required actions for the user - INSPECT the inventory for the affected Model number, serial number(s), and date of manufacture. - IF USER HAVE affected devices Contact Customer Technical Services or Sales Representative for correction. - RETURN the enclosed acknowledgement form to Mediana USA service center. - UPGRADE THE S/W with the received s/w according to the instruction. - IF ANY Problem occurred during the upgrade Contact Customer Technical Services or Sales Representative. If you have any questions, contact QMS Representative at +82 70 7092 9945; email: [email protected]. or Sales Representative at +82 70 7092 9525; email: [email protected]. or Technical Services at 425-406-2262; email: [email protected].
Quantity in commerce: 618
Distribution: US Distribution to: Wisconsin only
Product codes and lots: Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2096-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2096-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-19

Product code DXN

K200434Class IIV20, V20a, AVSM3 SNFMediana Co., Ltd. / cleared 2020-10-09

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)