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 LR051A58B027LR051A58B028and 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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