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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dual Energy Viewer

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 Class 2 Recall
syngo Dual Energy Viewer
see related information
Date Posted January 08, 2009
Recall Status1 Open
Recall Number Z-0647-2009
Recall Event ID 50500
Premarket Notification
510(K) Number
K052775 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.
Code Information Software versions: syngo MMW 2007C, syngo MMWP 2008A, syngo MMWP 2008B, syngo MMWP 2008C, syngo CT 2007A, and syngo CT 2008G.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Michael Van Ryn
610-448-4500
Manufacturer Reason
for Recall
Indicated orientation does not match actual orientation of the patient.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider "no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via "Save Sets CT"-button." The firm also highly recommends for customers "to check the correct display of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect to the posterior marking in the image." The error should be fixed within certain upgrade and installation activities on the affected software.
Quantity in Commerce 374 units
Distribution Nationwide Distribution
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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