PlainRecalls
FDA Devices Moderate Class II Terminated

Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .

Reported: June 12, 2013 Initiated: March 18, 2013 #Z-1369-2013

Product Description

Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .

Reason for Recall

The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.

Details

Recalling Firm
Shimadzu Medical Systems
Units Affected
200 units
Distribution
US Nationwide Distribution
Location
Torrance, CA

Frequently Asked Questions

What product was recalled?
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .. Recalled by Shimadzu Medical Systems. Units affected: 200 units.
Why was this product recalled?
The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 12, 2013. Severity: Moderate. Recall number: Z-1369-2013.