Mar

2014

Cl II Siemens syngo Dynamics PACS

Company: Siemens Healthcare Diagnostics, Inc..
Date of Enforcement Report:3/26/2014
Class lI:

PRODUCT

syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Recall Number Z-1216-2014

REASON
Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis..

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE on 1/27/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
50p>

DISTRIBUTION
Nationwide and Internationally

___________________________________

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 Dynamics PACS

Amy Sellers

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