Shimadzu Trinias Unity Catheterization Table Movement Control Defect
Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall addressing a control malfunction in medical equipment used during invasive procedures. No illnesses or injuries have been reported in the source material. The recall is classified as High severity because it involves potential patient safety risk during angiography procedures, though actual harm has not yet been documented.
Plain-English summary
Shimadzu Corporation Medical Systems Division is recalling 13 units of the Trinias unity Digital Angiography System with Catheterization Table (Model KS-100) due to a control malfunction. This medical device is used in clinical settings for angiography procedures.
The recalled systems have a control issue affecting the catheterization table. When an operator uses the direct memory button to move both the catheterization table and C-arm simultaneously and then releases the button, the table may continue moving. Although operators can stop the table using the stop button, the unintended motion creates a potential safety risk during the procedure.
The 13 affected units were distributed nationwide in Massachusetts, Illinois, South Carolina, Kentucky, Ohio, and Tennessee. Affected equipment is identified by UDI-DI codes 04540217058327, 04540217049066, and 04540217058143, along with 13 specific serial numbers.
Healthcare facilities operating these systems should contact Shimadzu Corporation for further guidance. Operators should be aware of this control issue when using simultaneous table and C-arm movements.
The recalled product
- Product
- Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
- Manufacturer
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Hazard
- equipment-malfunction
- unintended-motion
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 (15)
- UDI-DI: 04540217058327
- 04540217049066
- 04540217058143 Serial Numbers: 41EFCD7AC001
- 41E58C773001
- 41EFCD79C001
- 41EFCD78B001
- 41EFC73A9001
- 41EFCD7D4001
- 41E58C76B001
- 41EFC73D9001
- 41EFCD77C001
- 41EFC73A5001
- 41EFC73C5001
- 41EFCD79A001
- 41EFCD7A6001.
Distribution
Distributed nationwide across the United States.
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