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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

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