Mammomat Novation Digital Mammography System. Model number 6646900
FDA device recall Z-1045-05 · posted 2005-07-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- potential issue (image acquisition may become interrupted) when using multiple network nodes
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 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.
- Date initiated
- 2005-05-25
- Date posted
- 2005-07-28
- Date terminated
- 2006-08-30
- Location
- Malvern, PA
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