SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
FDA Recall Z-0742-2017 · Posted None
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-11-15
Date Terminated2018-04-27
Product Quantity104 systems
Reason for Recall
Software update that provides software and firmware bug-fixes to improve system performance
Firm Action
Siemens mailed a Customer Information Letter to affected customers on November 21, 2016 informing them of software updates that would provide bug-fixes to improve system performance and stability for customers with SOMATOM Definition AS, Definition Edge and Definition Flash systems using Software versions VA48A_SP1 and VA48A_SP2. The update will remotely be pushed to their systems or customers will be contacted by one of Siemens service organization to arrange a date for installation of the update on site. Customers with questions were instructed to call 1-800-888-7436.
Root Cause
Software Design Change
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement