FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Mammomat Novation Digital Mammography System. Model number 6646900
- Recall number
- Z-1045-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Mammomat Novation Digital Mammography System. Model number 6646900
- Status
- Terminated
- Initiated
- 2005-05-25
- Posted
- 2005-07-28
- Terminated
- 2006-08-30
- Reason
- potential issue (image acquisition may become interrupted) when using multiple network nodes
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P030010"]
- Product code
- not on file
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28