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Terminated

SOMATOM Definition Flash 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-0743-2017 · Posted None

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.

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