Reported Jun 12, 2013 · Terminated
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography…
Shimadzu Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shimadzu Medical Systems · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- 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 .
- Lot codes and dates
- In combination with CXDI-70CSerial
- Numbers
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
- In combination with CXDI-55CSerial
- NumbersIn combination
0162S658050162S658100162S658080162S660010162S660080162S658090162S660040162S660050162S660090162S660100162S662010162S662020162S662070162S662080162S662060162S663020162S664020162S664090162S664100162S664030162S665010162S664050162S664070162S664060162S665050162S665020162S665030162S664080162S665040162S666030162S665080162S665070162S665100162S667090162S666010162S666100162S666090162S66605
- with CXDI-55G Serial Numbers
0162S662050162S663070162S663090162S659010162S660030162S663060162S663080162S665090162S657090162S666060162S668020162S66803
- Amount recalled
- 200 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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