FDA Medical Device Recalls (openFDA)
General Electric Med Systems: Seneographe 800T Mammography X-Ray Systems
- Recall number
- Z-0285-04
- Recalling firm
- General Electric Med Systems
- Product
- Seneographe 800T Mammography X-Ray Systems
- Status
- Terminated
- Initiated
- 2004-02-06
- Posted
- 2004-07-20
- Terminated
- 2005-11-23
- Reason
- The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
- Root cause
- Other
- Action
- The consignees were sent 'Regulatory Notice' letters dated February 6, 2004. The letters informed the consignees of the violations and provided them with the technical specifications which needed to be provided.
- Quantity
- not on file
- Distribution
- Nationwide in the United States
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K953250"]
- PMA numbers
- not on file
- Product code
- IZH
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- 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