Shimadzu recalls TRINIAS medical imaging devices for potential fluoroscopy errors and image corruption during cardiac/neurovascular procedures. Affected units have specific serial numbers.
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.
Shimadzu is recalling TRINIAS medical imaging devices used in cardiac and neurovascular procedures due to two issues: errors that cause the device to stop working after a patient registration mistake, and rare image corruption that could make it hard to see objects during procedures.
Event 1 causes the device to stop working if a user starts fluoroscopy before completing the first patient registration, requiring service intervention. Event 2 creates rare image corruption that could make objects difficult to see during procedures due to data transmission errors.
Healthcare professionals using TRINIAS devices for cardiac and neurovascular imaging procedures are most at risk. Patients undergoing these procedures may be affected if the device malfunctions.
Check if your TRINIAS device has one of the listed serial numbers: 41B247746001, 41B24774C001, 41E58C757001, 41E58C765001, 41E58C766001, 41E58C769001, 41E58C76B001, 41E58C773001, 41E58C775001, 41E58C776001, 41E58C777001, 41E58C977001, 41EFCD77C001.
Identify your TRINIAS device's serial number to see if it matches the listed affected numbers.
Shimadzu Medical Systems will provide guidance on next steps if your device is affected.
The recall addresses two issues: errors that cause the device to stop working after a patient registration mistake, and rare image corruption that could make objects difficult to see during procedures.
No, but if your device has an affected serial number, contact Shimadzu for guidance on next steps.
Shimadzu will provide guidance on next steps if your device has an affected serial number.
We’ve drafted a message you can send Shimadzu Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0864-2019 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0864-2019 from Shimadzu Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
