Fischer SenoScan True View Digital Mammography System.
FDA device recall Z-1094-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Fischer Imaging Corporation
- Reason for recall
- Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
- Action taken
- Customers were notified by phone and certified letter on 05/21/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 12 units
- Distribution
- FL, NC, NY, OK, WI. Foreign distribution to France.
- Date initiated
- 2004-05-21
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-16
- Location
- Denver, CO
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