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U.S. Department of Health and Human Services

Class 3 Device Recall Mammomat Novation Digital Mammography System

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 Class 3 Device Recall Mammomat Novation Digital Mammography Systemsee related information
Date Initiated by FirmMay 25, 2005
Date PostedJuly 28, 2005
Recall Status1 Terminated 3 on August 30, 2006
Recall NumberZ-1045-05
Recall Event ID 32515
PMA NumberP030010 
ProductMammomat Novation Digital Mammography System. Model number 6646900
Code Information Serial numbers 1001, 1009, 1019, 1020, 1021, 1024, 1035, 1038, 1039, 1044, 1045, 1046, 1047, 1051, 1052, 1054, 1055, 1058, 1060, 1063, 1064, 1105, 1107, 1108, 1114, 1208, 1209, 1210, 1211, 1212, 1214, 1216, 1217, 1220, 1224, 1227, 1228, 1229, and 1234.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactRoland Richter
610-448-1777
Manufacturer Reason
for Recall		potential issue (image acquisition may become interrupted) when using multiple network nodes
FDA Determined
Cause 2		Other
ActionThe recalling firm has respresentatives/engineers hand carrying Customer Advisory Letters to their customers. The engineers are temporarily reconfiguring the ssytem to allow routing to only two network nodes in order to prevent this issue from occuring.
Quantity in Commerce33 units
DistributionNationwide. The products were shipped to medical facilities in AL, CA, FL, GA, IL, LA, MO, NC, NJ, NV, NY, SC, TX, VA, and WV.
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.
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