FDA Medical Device Recalls (openFDA)
Mediana Co., Ltd.: 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.
- Recall number
- Z-2441-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-05-15
- Posted
- not on file
- Terminated
- 2022-09-16
- Reason
- Failures were found in the temperature measurement function while in the predict mode.
- 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
- 180 devices
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Serial Numbers: 456802000001~456802000180
- 510(k) numbers
- ["K170497"]
- 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