Z-2293-2011

syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a...

Name: Z-2293-2011 syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a...
Creator: Siemens Medical Solutions, USA, Inc
Published: 2011-03-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-03-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions, USA, Inc began a recall of syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended... on 2011-03-24. The reason FDA records is "If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2293-2011
Status: Terminated
Initiated: 2011-03-24
Posted: 2011-05-25
Terminated: 2012-07-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.
Root cause tag: software
FDA root cause: Software design
Action: The firm, SIEMENS, sent a "Customer Safety Advisory Notice" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks. If you have any questions, call +1 (734) 205-2400.
Quantity in commerce: 29 devices
Distribution: Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.
Product codes and lots: 10091602, 10091604

Product code LLZ

K102150Class IISyngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. / cleared 2010-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)