Dec

2008

Cl Ill syngo MultiModality WorkPlace

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 12/10/2008
Class:lll

PRODUCT
syngo MultiModality WorkPlace (MM WP). Software product (Model Number 10140720). The product is intended for use in picture archiving and communications system; Recall # Z-0324-2009

REASON
Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern , PA , by visit beginning September 12, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen , Germany . Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
84 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 Ill syngo MultiModality WorkPlace

Amy Sellers

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