Shimadzu recalls Bransist Safire digital angiography systems with MS-200 ceiling suspended C-arm support due to software causing unintended arm movement after release. Affected units have specific serial numbers.
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 Bransist Safire digital angiography systems that contain a MS-200 ceiling suspended C-arm support. The software issue could cause the ceiling arm to move after the operator releases the movement lever, potentially causing harm to patients or the operator.
The control software for the ceiling arm can move unexpectedly after the operator releases the movement lever. This unintended movement could cause the arm to collide with the patient or the operator, leading to potential injury.
Medical professionals using the Bransist Safire system for X-ray procedures are most at risk. Patients undergoing angiography or cardiology procedures may also be affected.
Check for the Bransist Safire digital angiography system with MS-200 ceiling suspended C-arm support. Affected units have specific serial numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, 091X955901.
Review the system for unintended movement of the ceiling arm after releasing the movement lever.
The control software could cause the ceiling arm to move after the operator releases the movement lever, potentially causing collision or harm to the patient or operator.
Check if your Bransist Safire system has one of the specific serial numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, or 091X955901.
The official recall notice does not specify a remedy or action steps for affected units.
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-0554-2021 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-0554-2021 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.