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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imaging

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  Class 2 Device Recall Syngo Imaging see related information
Date Initiated by Firm October 28, 2015
Date Posted November 20, 2015
Recall Status1 Terminated 3 on October 06, 2016
Recall Number Z-0319-2016
Recall Event ID 72576
510(K)Number K071114  K081734  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo Imaging VB36D_HF02. Radiological image processing system.
Code Information model# 10014063 and 10014064
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-6300
Manufacturer Reason
for Recall		 To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.
FDA Determined
Cause 2		 Software change control
Action Siemens sent an Customer Information Letter dated October 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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) 219-6300.
Quantity in Commerce 3
Distribution US Distribution to the states of : NC, NE and OH.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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