Trinias unity recall
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm…
Why was Trinias unity recalled?
If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
- Product
- Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm…
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Quantity
- 13
- Distribution
- US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
- Recall date
- October 30, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)