Shimadzu Medical Systems recalls Trinias Digital Angiography Systems with a software issue that could cause the ceiling arm to move unexpectedly after release, risking patient or operator harm.
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Shimadzu is recalling Trinias Digital Angiography Systems that have a software problem with the ceiling arm. If the operator releases the movement lever, the arm might move unexpectedly, potentially causing injury to the patient or operator.
The software issue causes the ceiling arm to move after the operator releases the movement lever. This unintended movement could lead to collisions or harm to either the patient or the system operator during medical procedures.
Healthcare professionals using the Trinias system for medical imaging procedures are most at risk. Patients undergoing these procedures could also be affected if the arm moves unexpectedly.
Check for the Trinias Digital Angiography System with the MH-200 Ceiling Suspended C-arm Support. Affected units have specific serial numbers listed in the recall notice.
Review the system for unexpected movement of the ceiling arm after releasing the movement lever.
This recall affects Trinias Digital Angiography Systems with the MH-200 Ceiling Suspended C-arm Support that have specific serial numbers listed in the recall notice.
The recall does not specify a remedy, so contact Shimadzu Medical Systems directly for guidance.
Yes, the software issue could cause the ceiling arm to move unexpectedly, potentially resulting in harm to the patient or operator.
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-0555-2021 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0555-2021 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.
