Jan

2009

Cl Il CT syngo Dual Energy Viewer

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 1/14/2009
Class:ll

PRODUCT
CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System, Recall # Z-0647-2009

REASON
Indicated orientation does not match actual orientation of the patient..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated October 8, 2008.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
374 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 Il CT syngo Dual Energy Viewer

Amy Sellers

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