Date Initiated by Firm | June 11, 2015 |
Date Posted | July 02, 2015 |
Recall Status1 |
Terminated 3 on March 24, 2017 |
Recall Number | Z-1972-2015 |
Recall Event ID |
71507 |
510(K)Number | K071114 K081734 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. |
Code Information |
model number: 10014064 serial numbers: 5846 5847 4333 4334 4335 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
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For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer Reason for Recall | During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size. |
FDA Determined Cause 2 | Software design |
Action | Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary. |
Quantity in Commerce | 5 |
Distribution | US in the states of NC and NE |
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
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