• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo Imaging XS, versions VA70A and VA70B Client/Server Installations

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Siemens syngo Imaging XS, versions VA70A and VA70B Client/Server Installations
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on January 24, 2014
Recall Number Z-0515-2012
Recall Event ID 60424
Premarket Notification
510(K) Number
K082430 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image processing system
Code Information Model number 10496279
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
Unintended behavior when using syngo Imaging XS, versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended deletion of images/series.
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory letter dated August 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistenceis in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.
Quantity in Commerce 12
Distribution Nationwide Distribution including the states of CA, IN, IA, NV, NE, NY, OH, TN and TX.
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
-
-