Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to perform CT scans and nuclear imaging studies with the same instrument, obtaining attenuation corrected images and providing registration of anatomical and physiological images within the patient's anatomy. The Symbia T6 System is used for advanced oncology, neurology and cardiology applications.
FDA Recall Z-0189-2009 · Posted 2008-10-27
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Reason for Recall
Firm Action
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide to the District of Columbia, Florida, Georgia, Illinois, Indiana, Missouri, Ohio, and Texas, and internationally to Australia, Brazil, Canada, Great Britain, India, Italy, Japan, Norway and Switzerland.
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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