FDA-Device2019-03-27Class II
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 (DR).
Shimadzu Medical Systems Usa Com
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.
Sold states
US Nationwide Distribution
Affected count
93 units
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
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 (DR).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2019Don't want to check this manually?
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