Z-1045-05

Mammomat Novation Digital Mammography System. Model number 6646900

Name: Z-1045-05 Mammomat Novation Digital Mammography System. Model number 6646900
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-05-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-05-25 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mammomat Novation Digital Mammography System. Model number 6646900 on 2005-05-25. The reason FDA records is "potential issue (image acquisition may become interrupted) when using multiple network nodes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1045-05
Status: Terminated
Initiated: 2005-05-25
Posted: 2005-07-28
Terminated: 2006-08-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mammomat Novation Digital Mammography System. Model number 6646900
Reason for recall: potential issue (image acquisition may become interrupted) when using multiple network nodes
FDA root cause: 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.
Product codes and lots: 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.

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)