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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo.plaza with software version VA20B_HF04

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  Class 2 Device Recall Siemens syngo.plaza with software version VA20B_HF04 see related information
Date Initiated by Firm January 20, 2012
Date Posted February 29, 2012
Recall Status1 Terminated 3 on September 29, 2012
Recall Number Z-1127-2012
Recall Event ID 61141
510(K)Number K093612  
Product Classification System, image processing, radiological - Product Code LLZ
Product Siemens syngo.plaza with software version VA20B_HF04

Product Usage:
Radiological image processing system
Code Information Model number 10592457 - serial numbers 100138, 100263, 100249, 100201, 100198, 100181 and 100146.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall		 There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this can happen when an archive server with a USB dongle-based license is enabled with auto archiving. If the disk fill level is reached which triggers auto deleti
FDA Determined
Cause 2		 Software design
Action Siemens sent a Customer Safety Advisory Notice letter dated January 20, 2012 to all affected consignees. The letter identified the affected product, problem, steps to take to avoid this issue, and actions to be taken. Customers were instructed to contact their local Siemens Service to plan for their software update and ensure that this safety advisory is placed in the system's instruction for use.
Quantity in Commerce 7
Distribution Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.
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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