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Recall Observatory FDA recall evidence

Device product

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.

Z-0019-2016

August 14, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 72091
Status
Terminated
Classification
Class II
Quantity
113 total
Official record key
device-enforcement:Z-0019-2016

Official wording

Reason: 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

Code information: Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software bug