Reported Feb 27, 2019 · Terminated
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography,…
Shimadzu Medical Systems USA Com
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 Medical Systems Usa Com · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
- Lot codes and dates
- Serial Numbers
41B24774600141B24774C00141E58C75700141E58C76500141E58C76600141E58C76900141E58C76B00141E58C77300141E58C77500141E58C77600141E58C77700141E58C97700141EFCD77C001
- Serial Numbers
- Amount recalled
- 13 units
Where it was sold
Why it was recalled
Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
This product could cause temporary or reversible health problems — stop using it.
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