CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Trinias unity, Digital Angiography System with Catheterization Table recalled
Shimadzu Corporation Medical Systems Division is recalling Trinias unity, Digital Angiography System with Catheterization Table, distributed nationwide in the US. The recall was initiated on 6 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0139-2025
- FDA event ID
- 95406
- Recalling firm
- Shimadzu Corporation Medical Systems Division, Kyoto, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Sep 2024
- FDA classified
- 22 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 6 Sep 2024 | Recall initiated by company | |
| 22 Oct 2024 | Classified by FDA | +46 days |
| 30 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
Nationwide IllinoisKentuckyMassachusettsOhioSouth CarolinaTennessee
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.
Where was it sold?
US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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