FDA Medical Device Recalls (openFDA)
Mediana Co., Ltd.: 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.
- Recall number
- Z-2096-2021
- 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.
- Status
- Terminated
- Initiated
- 2021-05-17
- Posted
- not on file
- Terminated
- 2022-11-04
- Reason
- In some cases the equipment fails to power up and/or key or button unresponsive or not working.
- 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: 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.
- Quantity
- 618
- Distribution
- US Distribution to: Wisconsin only
- Lot, serial or model codes
- Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066
- 510(k) numbers
- ["K200434"]
- PMA numbers
- not on file
- Product code
- DXN
- Firm FEI
- 3003591740
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28