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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dynamics version 9.0

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 Class 2 Recall
syngo Dynamics version 9.0
see related information
Date Posted May 25, 2011
Recall Status1 Terminated on July 10, 2012
Recall Number Z-2293-2011
Recall Event ID 58545
Premarket Notification
510(K) Number
K102150 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.
Code Information 10091602, 10091604
Recalling Firm/
Manufacturer
Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor, Michigan 48108
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
If one or more graphs are in a table on the report, and if any of those graphs are deleted, it may lead to reports failing to save and/or marking the study as read might leave the study in an unread state or might mark the study as read but leave the report with a "Preliminary" watermark displayed.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, SIEMENS, sent a "Customer Safety Advisory Notice" letter dated March 24, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to place graphs in sections and not tables in the report; avoid deleting graphs from the reports in run-time and include this safety advisory notice in their operator's manual where it should remain until the service patch is applied. SIEMENS will be issuing a service patch to fix the defect. The letter states the patch will be available in the next few weeks. If you have any questions, call +1 (734) 205-2400.
Quantity in Commerce 29 devices
Distribution Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.
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 MEDICAL SOLUTIONS USA, INC.
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