FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.
- Recall number
- Z-1041-2011
- Recalling firm
- GE Healthcare, LLC
- Product
- GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.
- Status
- Terminated
- Initiated
- 2011-01-19
- Posted
- 2011-03-18
- Terminated
- 2012-05-16
- Reason
- During installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the X-ray Generator Cabinet was missing from the installation kits that allow installation of the Senographe Essential in a van (mobile unit).
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The firm plans to repair the defect or to bring product into compliance. The field action is being implemented to inspect the affected units and if found to be missing the certification label, a certification label will be applied. This will be carried out via a Field Modification Instruction planned to be released in March, 2011 with an estimated completion date of July, 2011.
- Quantity
- 14
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All associated serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MUE
- 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