Aug

2012

Cl ll Siemens syngo.plaza image processing system

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 8/112
Class ll:

PRODUCT
Siemens syngo.plaza. Radiological image processing system. Z-2078-2012

REASON
Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc , Malvern, PA on 2/24/2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

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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Cl ll Siemens syngo.plaza image processing system

Amy Sellers

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