Date Initiated by Firm | May 22, 2017 |
Create Date | November 21, 2017 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-0168-2018 |
Recall Event ID |
77456 |
510(K)Number | K132532 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171
Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications. |
Code Information |
non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0) |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | Anastasia Sokolova 610-448-6478 |
Manufacturer Reason for Recall | Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System. |
FDA Determined Cause 2 | Software design |
Action | Siemens sent an Customer Information Letter dated May 17, 2017.
Customers Instructions:
If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 448-6478. |
Quantity in Commerce | 2 units |
Distribution | Distribution to MN |
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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