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U.S. Department of Health and Human Services

Class 2 Device Recall syngo US Workplace

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 Class 2 Device Recall syngo US Workplacesee related information
Date Initiated by FirmDecember 06, 2007
Date PostedMay 20, 2008
Recall Status1 Terminated 3 on December 20, 2010
Recall NumberZ-1138-2008
Recall Event ID 46373
510(K)NumberK060992 
Product Classification patient image archiving system - Product Code LLZ
Productsyngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
Code Information Material number: 10035829, serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebire Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact
650-694-5993
Manufacturer Reason
for Recall		Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
FDA Determined
Cause 2		Software design
ActionSiemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days.
Quantity in Commerce17 units
DistributionWorldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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