| Class 3 Device Recall Mammomat Novation Digital Mammography System | |
Date Initiated by Firm | May 25, 2005 |
Date Posted | July 28, 2005 |
Recall Status1 |
Terminated 3 on August 30, 2006 |
Recall Number | Z-1045-05 |
Recall Event ID |
32515 |
PMA Number | P030010 |
Product | Mammomat 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
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For Additional Information Contact | Roland 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 |
Action | The 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 Commerce | 33 units |
Distribution | Nationwide. The products were shipped to medical facilities in AL, CA, FL, GA, IL, LA, MO, NC, NJ, NV, NY, SC, TX, VA, and WV. |
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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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