Shimadzu Medical Systems Usa Com recalls SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to t…

Recall date

January 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1039-2019

FDA classification

Class II

Brand / firm

Shimadzu Medical Systems Usa Com

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).