Shimadzu Medical Systems recalls MH-200S X-Ray systems with ceiling suspended C-arm support due to software causing ceiling arm movement after release. Affected serial numbers listed. Stop using immediately to prevent patient or operator injury.
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 recalls specific models of X-ray systems used for medical imaging because a software issue might cause the ceiling arm to move unexpectedly after the operator releases the movement lever. This could lead to collisions or injuries for patients or medical staff if the system is used without correction.
The control software for the ceiling arm can move after the operator releases the movement lever. This unintended movement might cause the arm to collide with the patient or operator, potentially causing injury during medical procedures.
Medical facilities using Shimadzu MH-200S X-ray systems with ceiling suspended C-arm support for procedures like cardiac angiography are affected. Patients and medical staff using these systems without the software fix are at risk of injury.
Check if your X-ray system has the model name 'MH-200S' with ceiling suspended C-arm support. Affected units have specific serial numbers listed in the recall notice, including 0161K35901 through 0161K56502.
Immediately cease using the affected X-ray system to prevent potential collisions or injuries.
The Shimadzu MH-200S system with ceiling suspended C-arm support used for cardiac angiography and other medical imaging procedures.
The ceiling arm might move unexpectedly after the operator releases the movement lever, potentially causing injury to the patient or medical staff.
Check the serial number against the list of affected numbers provided in the recall notice, which includes models like 0161K35901 through 0161K56502.
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-0556-2021 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0556-2021 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.
