Siemens Medical Solutions USA Class I

Company: Siemens Medical Solutions USA
Date of Enforcemet Report: 8/14/02
Class: I

PRODUCT
e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2.

REASON
Incorrect image time stored for static images resulting in incorrect results.

CODE
e.soft software version 2.0 installed on e.soft A and e.soft A/P workstations.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters and CD on July 12, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
346 units.

DISTRIBUTION
Nationwide and Internationally.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.