Shimadzu Medical Systems recalls MX8 Mobile X-Ray systems that may continue moving if operator releases handle without braking. Affected units have serial numbers starting with 41F41DD7C001 to 41F41DD85004. No remedy provided.
In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.
Shimadzu Medical Systems is recalling certain MobileDaRt Evolution (MX8) mobile X-ray systems that may continue moving if the operator releases the handle without properly applying the brakes. This could cause the device to coast unexpectedly while in motion, potentially leading to injury if it moves toward patients or staff.
In these units, the brake is supposed to be released by gripping the handle and applied by letting go. However, for some units made within a specific timeframe, the brakes don't apply when the handle is released. If the operator releases the handle while the device is moving, the unit will continue coasting without stopping, which could cause injury to patients or staff.
Healthcare workers using mobile X-ray systems in hospitals or emergency settings who operate these devices with patients who cannot move. Patients receiving X-rays from these systems are at risk if the device moves unexpectedly.
Check for serial numbers starting with 41F41DD7C001 through 41F41DD85004 as listed in the recall notice. These units were manufactured between specific dates indicated in the serial numbers.
Look for serial numbers starting with 41F41DD7C001 through 41F41DD85004 as listed in the recall notice.
The brake system in some units may not apply when the handle is released, causing the device to continue moving unexpectedly if the operator releases the handle while in motion.
Check if your device has a serial number starting with 41F41DD7C001 through 41F41DD85004 as listed in the recall notice.
The recall notice does not provide a remedy, so contact Shimadzu Medical Systems for further instructions.
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-1039-2019 — Shimadzu Medical Systems Shimadzu Medical Systems Hello, I own a Shimadzu Medical Systems that is covered by recall Z-1039-2019 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.
