Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 10/14/2015
Class lI:

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.
Recall Number Z-0019-2016

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 processing coupled to Twin Beam examinations. 5) Correction to assure proper communication between system components. 6) Correction to improve robustness of ECG triggering.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 8/14/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
113 total

DISTRIBUTION
Nationwide

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