May

2009

Cl Il syngo Imaging

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/6/2009
Class:ll

PRODUCT
syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system. Recall # Z-1266-2009

REASON
An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).

RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter dated 02/09/2009.
Manufacturer: Siemens Ag Healthcare Sector, Erlangen, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20 units

DISTRIBUTION
AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI

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 syngo Imaging

Amy Sellers

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