FDAJanuary 14, 2019device
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
shimadzu medical systems usa comshimadzushimadzu medical
UPCs
04540217059621
Recall history
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