| Class 2 Device Recall Siemens syngo Dynamics |  |
Date Initiated by Firm | January 27, 2014 |
Date Posted | March 18, 2014 |
Recall Status1 |
Terminated 3 on March 16, 2015 |
Recall Number | Z-1216-2014 |
Recall Event ID |
67559 |
510(K)Number | K023772 K102150 |
Product Classification |
Picture Archiving and Communication System (PACS) - Product Code LLZ
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Product | syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 |
Code Information |
Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer Reason for Recall | Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis. |
FDA Determined Cause 2 | Software design |
Action | A recall notification letter, dated January 27, 2014, was sent to end Users. Customer Safety Advisory Letter SY016/14/S. Siemens is preparing a Service Patch modification of syngo Dynamics v9.5 which will be available in March 2014. |
Quantity in Commerce | 50 |
Distribution | Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA. |
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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510(K) Database | 510(K)s with Product Code = LLZ 510(K)s with Product Code = LLZ
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