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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Shimadzu Medical Systems
Lot Codes / Batch Numbers
Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.
Products Sold
Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.
Shimadzu Medical Systems is recalling Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - due to The DAP meters were found to be outside of tolerance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The DAP meters were found to be outside of tolerance.
Recommended Action
Per FDA guidance
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.
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 noticePage updated: Jan 10, 2026