Recalls / —

—#40241

Product

Mammomat Novation Digital Mammography System. Model number 6646900

PMA numbers

P030010

Affected lot / code info

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.

Why it was recalled

potential issue (image acquisition may become interrupted) when using multiple network nodes

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2005-05-25

Posted by FDA

2005-07-28

Terminated

2006-08-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #40241. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.