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Shimadzu Medical Systems Usa Com recalls SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used t
Recalled March 27, 2019 · FDA recall Z-1039-2019 · 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. · FDA Class II
Units
93 units
Sold at
US Nationwide Distribution
Description
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.
Product
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).
Manufacturer(s)
Shimadzu Medical Systems Usa Com
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →