SOMATOM Definition Edge; 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-0019-2016 · Posted 2015-10-05
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2015-08-14
Date Terminated2016-12-05
Product Quantity113 total
Reason for Recall
software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
Firm Action
A customer advisory notice, dated 8/14/15, was sent to direct accounts advising them of the issue to observe the safety notice and comply with the corresponding measure until the update has been fully completed.
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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