Date Initiated by Firm | April 06, 2010 |
Date Posted | June 24, 2010 |
Recall Status1 |
Terminated 3 on July 05, 2012 |
Recall Number | Z-1892-2010 |
Recall Event ID |
55651 |
510(K)Number | K082430 |
Product Classification |
Image Processing Radiological System - Product Code LLZ
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Product | Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS. |
Code Information |
Material number 10014063. Serial numbers 1043, 1114, and 1198. Version Lines VB20, VB30, & VB35. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Customer Service 610-219-6300 |
Manufacturer Reason for Recall | Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs. |
FDA Determined Cause 2 | Device Design |
Action | The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded. |
Quantity in Commerce | 3 units |
Distribution | Nationwide Distribution -- Including CT, NM, & WI. |
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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