CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
Trinias Digital Angiographic System intended to be used recalled
Shimadzu Medical Systems Usa Com is recalling Trinias Digital Angiographic System intended to be used for cardiac angiography, distributed in Louisiana. The recall was initiated on 15 Jun 2018 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-0197-2019
- FDA event ID
- 81080
- Recalling firm
- Shimadzu Medical Systems Usa Com, Torrance, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2018
- FDA classified
- 19 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 15 Jun 2018 | Recall initiated by company | |
| 19 Oct 2018 | Classified by FDA | +126 days |
| 31 Oct 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Where it was distributed
Domestic: LA
Questions about this recall
Why was it 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.
Which lots are affected?
Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001
Where was it sold?
Domestic: LA
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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