FDA Medical Device Recalls (openFDA)
Fischer Imaging Corporation: SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
- Recall number
- Z-0757-06
- Recalling firm
- Fischer Imaging Corporation
- Product
- SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
- Status
- Terminated
- Initiated
- 2006-03-27
- Posted
- 2006-04-11
- Terminated
- 2012-03-13
- Reason
- Software upgrade to preclude lost images during mammography procedure.
- Root cause
- Other
- Action
- Consignees were notified by letter on 03/27/2006.
- Quantity
- 80 units.(Domestic) Foreign list pending
- Distribution
- Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military consignees.
- Lot, serial or model codes
- Software versions earlier than 5.2.2 Product Number 94001G-3, 105200G
- 510(k) numbers
- not on file
- PMA numbers
- ["P010017S007"]
- 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