Shimadzu Recalls Three Trinias DAP Meters for Tolerance Issues
Shimadzu Medical Systems is recalling three Trinias DAP Meters because they were found to be outside of tolerance. The devices are used in interventional procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a technical tolerance issue without reported adverse health consequences, fitting the Moderate category for low-risk or precautionary recalls.
Plain-English summary
Shimadzu Medical Systems is recalling three Trinias DAP Meters, which are components of the Digital Anglo System Trinias contained within the DAR-9500f. The recall is due to the devices being found to be outside of tolerance.
The affected devices are intended for use in interventional procedures, including invasive cardiology, interventional radiology, and interventional neuroradiology. The recall covers three specific units with serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.
The devices were distributed nationwide in the United States, including in Florida, Kentucky, and Louisiana. There was no distribution to government, military, or foreign entities. Healthcare facilities should check their inventory for these specific serial numbers and stop using the affected devices.
The recalled product
- 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.
- Manufacturer
- Shimadzu Medical Systems
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial numbers LR051A58B027
- LR051A58B028
- and LR051A58B029.
Distribution
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