Fischer SenoScan True View Digital Mammography System.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Fischer Imaging Corporation
- Recall Initiated
- May 21, 2004
- Posted
- July 20, 2004
- Terminated
- July 16, 2004
- Recall Number
- Z-1094-04
- Quantity
- 12 units
- Firm Location
- Denver, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
Distribution
FL, NC, NY, OK, WI. Foreign distribution to France.
Lot / Code Info
Product number 94829G-1, 94830G-1, 94830G-2.
Root Cause
Other
Action Taken
Customers were notified by phone and certified letter on 05/21/2004.
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