FDA Medical Device Recalls (openFDA)
Shimadzu Medical Systems: Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
- Recall number
- Z-2591-2020
- Recalling firm
- Shimadzu Medical Systems
- Product
- Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
- Status
- Completed
- Initiated
- 2019-11-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- The DAP meters were found to be outside of tolerance.
- Root cause
- Device Design
- Action
- The firm issued a Field Safety Notice dated 11/5/2019 via email on 11/4/2019 describing the issue in "Digital Angiography System Trinias." The local representative was going to correct the device at the consignee locations.
- Quantity
- 3 devices
- Distribution
- US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.
- Lot, serial or model codes
- Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.
- 510(k) numbers
- ["K123508"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1000125362
- Firm city
- Torrance
- Firm state
- CA
- 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