Reported Oct 30, 2024 · Ongoing
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the…
Shimadzu Corporation Medical Systems Division
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 CORPORATION MEDICAL SYSTEMS DIVISION · Nishinokyo Kuwabara -Cho · Kyoto, N/A · N/A
Is this the product you have?
- Trinias unity, Digital Angiography System with Catheterization Table
- ModelKS-100 This system consists
- of the following main componentsC arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component
- Lot codes and dates
- UDI-DI
045402170583270454021704906604540217058143
- Serial Numbers
41EFCD7AC00141E58C77300141EFCD79C00141EFCD78B00141EFC73A900141EFCD7D400141E58C76B00141EFC73D900141EFCD77C00141EFC73A500141EFC73C500141EFCD79A00141EFCD7A6001
- UDI-DI
- Amount recalled
- 13
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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