Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dynamics 9.0

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall syngo Dynamics 9.0 see related information
Date Initiated by Firm May 10, 2011
Date Posted July 08, 2011
Recall Status1 Terminated 3 on July 09, 2012
Recall Number Z-2762-2011
Recall Event ID 58830
Product Classification System, image processing, radiological - Product Code LLZ
Product syngo Dynamics Picture Archiving Communication System

The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.
Code Information Serial numbers 10091602 and 10091604
Recalling Firm/
Manufacturer		 Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor MI 48108
For Additional Information Contact Sandy Johanesen
800-422-8766
Manufacturer Reason
for Recall		 For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions, USA, Inc sent a letter entitled "Customer Safety Advisory Notice" to all direct accounts on May 10, 2011. The letter stated the name and version of the software, problem noted, a work-around to be implemented until a service patch is created to fix the problem, and that the letter should be placed in the software's operator's manual to be seen by all who utilize the software.
Quantity in Commerce 38
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-