Shimadzu TRINIAS Imaging Systems Recalled for Software and Display Errors
Shimadzu is recalling 13 TRINIAS imaging systems due to software crashes and rare display corruption that may hinder medical examinations.
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: The recall involves a risk-of-harm product (medical imaging) where the defect may hinder examination and treatment, but no injuries or illnesses have been reported.
Plain-English summary
Shimadzu Medical Systems USA is recalling 13 units of the TRINIAS diagnostic imaging system. The devices are used for various angiography and radiographic procedures. The recall covers units distributed in Florida, Montana, Connecticut, Ohio, Illinois, Texas, Mississippi, Louisiana, and South Carolina.
The recall addresses two specific issues. First, if a user powers up the device in the morning and starts a fluoroscopy while the first patient is still being registered, the application will abnormally terminate, requiring service intervention before the device can be used again. This issue does not occur after the first patient procedure. Second, in rare cases, external noise may cause a synchronization error in the data transmission circuit, resulting in corrupted or bit-shifted images. This may make it difficult to see the object being examined, potentially hindering the examination or treatment.
No injuries or illnesses have been reported in connection with this recall. Affected facilities should contact Shimadzu Medical Systems USA for instructions on how to resolve the issues.
The recalled product
- Product
- 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.
- Manufacturer
- Shimadzu Medical Systems Usa Com
- Affected units
- 13
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 (13)
- Serial Numbers: 41B247746001
- 41B24774C001
- 41E58C757001
- 41E58C765001
- 41E58C766001
- 41E58C769001
- 41E58C76B001
- 41E58C773001
- 41E58C775001
- 41E58C776001
- 41E58C777001
- 41E58C977001
- 41EFCD77C001
Distribution
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