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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Imaging XS

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  Class 2 Device Recall Syngo Imaging XS see related information
Date Initiated by Firm February 16, 2010
Date Posted April 20, 2010
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-1423-2010
Recall Event ID 55108
510(K)Number K082430  
Product Classification system, image processing, radiological - Product Code LLZ
Product Syngo Imaging XS model number 10496279

The intended use: image processing radiological
Code Information Model number 10496279. Serial numbers: 1165, 1213, 1361, 1373, 1395, and 1424.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Technical Solutions
888-826-9702
Manufacturer Reason
for Recall		 images can be overwritten
FDA Determined
Cause 2		 Software design
Action A "Customer (Safety) Advisory notice" dated February 16, 2010, was sent all affected customers via Update Instructions IM019/10/S. This notice describes the product, problem and the action to be taken by the customers. The customers should immediately instruct their employees of the advisor notice and maintain awareness. If the customer sold the device/equipment and is no longer in possession of it, they should forward the notice and inform Siemens of the new owner. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instructions IM020/10/S. If you have any further questions regarding this issue, do not hesitate to contact your local SIEMENS Uptime Service Center (michael.mib.braun@siemens.com).
Quantity in Commerce 6 units
Distribution Nationwide distribution: CA, NC, NY, PA, and TX
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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