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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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