Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
FDA Recall Z-0451-2016 · Posted None
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Recalling FirmShimadzu Medical Systems
Recall StatusTerminated
Product CodeIZL
Date Initiated2015-11-10
Date Terminated2016-10-27
Product Quantity297 units
Reason for Recall
The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Firm Action
Shimadzu sent an Urgent Voluntary Medical Device Recall Notice dated November 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter was sent to customers to inform them that Shimadzu is recalling the Mobile X-ray system MobileDaRt Evolution because of reports that an image was not transferred to image server properly. Customers with questions are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
Root Cause
Software design
Distribution Pattern
US Distribution and Internationally to Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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