Fujifilm recalls FDR Go PLUS mobile X-ray systems with serial numbers MQ0001281001 to MQ00012: The braking mechanism may not engage when the handle is released, potentially causing unintended movement during use.
FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
Fujifilm is recalling mobile X-ray systems that could have a braking mechanism that doesn't engage when the handle is released. This risk could lead to unintended movement of the device during use, which might cause injury to patients or staff.
The braking mechanism might not engage when the driving handle is released, which could cause the X-ray device to move unexpectedly during use. This unintended movement could potentially injure patients or staff if the device is not properly secured.
Healthcare facilities using the Fujifilm FDR Go PLUS mobile X-ray system for hospital patients or emergency outpatients are most at risk. The device is intended for use with patients who cannot move or are in emergency situations.
Check for serial numbers starting with MQ0001281001 through MQ0001285004 on the Fujifilm FDR Go PLUS mobile X-ray system. The device is used in hospitals for patients who cannot move or are in emergency situations.
Look for the serial number on the device, which should be between MQ0001281001 and MQ0001285004.
The braking mechanism might not engage when the driving handle is released, which could cause the device to move unexpectedly during use.
Check the serial number on the device; affected units have serial numbers from MQ0001281001 to MQ0001285004.
The recall record does not specify a remedy, so contact Fujifilm Medical Systems for further instructions.
We’ve drafted a message you can send Fujifilm Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1040-2019 — Fujifilm Medical Systems Fujifilm Medical Systems Hello, I own a Fujifilm Medical Systems that is covered by recall Z-1040-2019 from Fujifilm 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.
