FDA Medical Device Recalls (openFDA)
Fischer Imaging Corporation: Fischer SenoScan True View Digital Mammography System.
- Recall number
- Z-1094-04
- Recalling firm
- Fischer Imaging Corporation
- Product
- Fischer SenoScan True View Digital Mammography System.
- Status
- Terminated
- Initiated
- 2004-05-21
- Posted
- 2004-07-20
- Terminated
- 2004-07-16
- Reason
- Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
- Root cause
- Other
- Action
- Customers were notified by phone and certified letter on 05/21/2004.
- Quantity
- 12 units
- Distribution
- FL, NC, NY, OK, WI. Foreign distribution to France.
- Lot, serial or model codes
- Product number 94829G-1, 94830G-1, 94830G-2.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010017"]
- Product code
- MUE
- Firm FEI
- 1418957
- Firm city
- Denver
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28