Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full
FDA device recall Z-1233-2009 · posted 2009-05-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Image may appear dark, requiring repeat image acquisition.
- Action taken
- A Customer Safety Advisory Notice dated December 16, 2008 was issued to affected customers via Update Instructions SP040/08/S. The letter described the potential issue and provided instructions to avoid its occurrence. A software update to correct the issue is currently being developed and will be installed on affected systems when it becomes available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 497 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-01-23
- Date posted
- 2009-05-07
- Date terminated
- 2013-03-19
- Location
- Malvern, PA
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