FDA Recall
Terminated
Mammomat Novation Digital Mammography System. Model number 6646900
Recall: Z-1045-05
·
Initiated May 25, 2005
Recall
- Recall Number
- Z-1045-05
- Event Number
- 32515
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 25, 2005
- Posted
- July 28, 2005
- Terminated
- August 30, 2006
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355-1406
Description
Mammomat Novation Digital Mammography System. Model number 6646900
Reason
potential issue (image acquisition may become interrupted) when using multiple network nodes
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.
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.
Quantity
33 units