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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 Recall
Siemens syngo.plaza with software version VA20B_HF04
see related information
Date Posted February 29, 2012
Recall Status1 Terminated on September 29, 2012
Recall Number Z-1127-2012
Recall Event ID 61141
Premarket Notification
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, Pennsylvania 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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