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Terminated

Mammomat Novation Digital Mammography System. Model number 6646900

FDA Recall Z-1045-05 · Posted 2005-07-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Date Initiated2005-05-25
Date Terminated2006-08-30
Product Quantity33 units

Reason for Recall

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

Firm 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.

Root Cause

Other

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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