TRINIAS Digital Angiographic System intended to be used recall: Software Issue
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral…
Why was TRINIAS Digital Angiographic System intended to be used recalled?
Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001
- Product
- TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral…
- Recalling firm
- Shimadzu Medical Systems Usa Com
- Quantity
- 1
- Distribution
- Domestic: LA
- Recall date
- October 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)