Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
FDA Recall Z-0321-2009 · Posted 2009-01-05
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2008-09-03
Date Terminated2009-09-23
Product Quantity9 units
Reason for Recall
software error - does not allow protocol to properly synchronize with ECG triggers
Firm Action
The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.
Root Cause
Software design
Distribution Pattern
Nationwide
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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