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Class 2 Device Recall syngo Dynamics 9.0 |
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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
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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
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For Additional Information Contact |
Sandy Johanesen 800-422-8766
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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.
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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
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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.
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