Mar

2016

Cl II Siemens syngo X Workplace

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/30/2016
Class lI:

PRODUCT

syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional proceduress.
Recall Number Z-1232-2016

REASON
After importing, the segmentation results appear mirrored at the CARTO system and can’t be used for the ablation procedure.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/24/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6

DISTRIBUTION
Nationwide Distribution to IL, NY, MT, and MN.

___________________________________

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 II Siemens syngo X Workplace

Amy Sellers

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