21
May
2008

Siemens Syngo US Workplace Cl IlI

0

Company: Siemens Medical Solutions, Inc.,
Date of Enforcement Report 5/21/2008
Class:lll

PRODUCT
Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043. Material number: 10035829, Recall # Z-1138-2008

REASON
Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, Inc., Mountain View, CA, by letter dated November 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
17 units

DISTRIBUTION
Nationwide and Internationally

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.

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Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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