Product Wiki · Recalls · U.S. FDA — Device Enforcement

Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device… — recall Z-0451-2016

U.S. FDA — Device Enforcement · United States · 2015-11-10 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0451-2016
Date of alert
2015-11-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Shimadzu Medical Systems
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Distribution and Internationally to Canada
Reported risk: The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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