Inc Class II Siemens Medical Solutions USA

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 5/28/03
Class: II

PRODUCT
a) Leonardo MM-WS systems. System, Image Processing.
Recall # Z-0841-03;
b) Smatom Sensation 16, Computed Tomography System, Diagnostic
Imaging. Recall # Z-0842-03.

REASON
Perfusion CT is displaying a higher gray and color values than normal. A software problem.

CODE
a) Model Number 7129534;
b) Model Number 7393114.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA. Update instructions on the new software were sent on August 2, 2002 by mail. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
3.

DISTRIBUTION
OH, MA, and MO.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just 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, TX) and Canada.