AVSM3 SNF, Vital Signs Monitor recallZ-2096-2021 · Mediana Co., Ltd. · initiated May 17, 2021

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Mediana Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

In some cases the equipment fails to power up and/or key or button unresponsive or not working.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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].

Recall details

Recall number: Z-2096-2021
Status: Terminated
Initiated by the company: May 17, 2021
Recalling firm: Mediana Co., Ltd.
Quantity: 618
Product code: DXN
FDA submissions: K200434
Distribution: US Distribution to: Wisconsin only

Product description

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.

Code information (models, lots, serial numbers)

Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Direct Supply AVSM3
Mediana.CO.LTD · System, Measurement, Blood-Pressure, Non-Invasive
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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