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
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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
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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 |
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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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