Reported Jul 22, 2020 · Completed

Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It…

Shimadzu Medical Systems

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Shimadzu Medical Systems · 20101 S Vermont Ave · Torrance, CA · 90502-1328

Is this the product you have?

  • Trinias DAP Meter, a component of the Digital Anglo System Trinias contained
  • within the DAR-9500f - Product UsageIt is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology
Lot codes and dates
    • Serial numbers LR051A58B027
    • LR051A58B028
    • and LR051A58B029
Amount recalled
3 devices

Where it was sold

Why it was recalled

The DAP meters were found to be outside of tolerance.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:10 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.