FDA Device Recall Z-0019-2016: Siemens Medical Solutions USA, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2016.

Recall Res Number

Z-0019-2016

Recalling Firm / Manufacturer

Siemens Medical Solutions USA, Inc

FEI Number

2240869

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-08-14

Date Posted

2015-10-05

Date Terminated

2016-12-05

Product Code

JAK

Event Number

72091

Product Quantity

113 total

Product Description 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.

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

Action Details 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.

Distribution Pattern Nationwide Distribution.

Code Information / Serial Numbers Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279

Related Establishments / Registrations

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Medical Device Recall: Z-0019-2016

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer