AVSM3 SNF Monitor (Mediana) – Power Failure Risk (2021)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of)
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066
Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of) is recalling AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pres due to In some cases the equipment fails to power up and/or key or button unresponsive or not working.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
Recommended Action
Per FDA guidance
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: don@mediana.co.kr. or Sales Representative at +82 70 7092 9525; email: chris.shin@mediana.co.kr. or Technical Services at 425-406-2262; email: Jason.kim@medianausa.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
WI
Page updated: Jan 10, 2026