Shimadzu recalls TRINIAS Digital Angiographic Systems due to software causing C-arm to move unexpectedly during park position and operations, risking patient or staff contact. Affected units have specific model and serial numbers.
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.
Shimadzu is recalling TRINIAS Digital Angiographic Systems used for cardiac and other imaging procedures because a software issue may cause the C-arm to move unexpectedly, potentially contacting patients or healthcare workers. This could lead to injury if the C-arm moves during normal use.
The software issue causes the C-arm to move unexpectedly when being moved to park position or during specific operations. This movement could cause the C-arm to contact patients or healthcare personnel, potentially causing injury.
Healthcare facilities using the TRINIAS system for cardiac, neurovascular, or abdominal imaging procedures are most at risk. Patients and medical staff during procedures may be affected if the C-arm moves unexpectedly.
Check for the model number Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 and serial number 41E58C977001 on the device. The system is intended for cardiac, neurovascular, abdominal, and other imaging procedures.
Identify the model number and serial number on the TRINIAS system to confirm if it is affected.
Yes, if your facility uses the TRINIAS Digital Angiographic System for cardiac imaging procedures, it may be affected due to the software issue.
Check for the model number Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 and serial number 41E58C977001 on the device.
The recall record does not specify a remedy, so contact Shimadzu Medical Systems USA for further instructions.
We’ve drafted a message you can send Shimad:zu to request your refund or repair — edit it as you like.
Subject: Recall Z-0197-2019 — Shimad:zu Shimad:zu Hello, I own a Shimad:zu that is covered by recall Z-0197-2019 from Shimad:zu. 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.
