Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.
FDA Recall Z-1233-2009 · Posted 2009-05-07
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUE
Date Initiated2009-01-23
Date Terminated2013-03-19
Product Quantity497 units
Reason for Recall
Image may appear dark, requiring repeat image acquisition.
Firm Action
A Customer Safety Advisory Notice dated December 16, 2008 was issued to affected customers via Update Instructions SP040/08/S. The letter described the potential issue and provided instructions to avoid its occurrence. A software update to correct the issue is currently being developed and will be installed on affected systems when it becomes available.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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