| Class 2 Device Recall syngo Dynamics 9.0 | |
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 |
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 |
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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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