FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.
- Recall number
- Z-1519-2013
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.
- Status
- Terminated
- Initiated
- 2013-01-14
- Posted
- 2013-06-26
- Terminated
- 2013-11-26
- Reason
- GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare will notify customers with affected systems via letter and enclose a new CD- Rom, along with notification that a GE Representative will schedule an appointment to install the User's Manual along with a GE Service Engineer will go on site to install it on the control station of the Senograph Essential system. 16- H LA 6. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter. GE Healthcare will secure and summarize documentation that the manual has been installed and is available on each affected system and provide summarize of the documentation to the district recall coordinator. For further questions please call ( 262 ) 513-4122.
- Quantity
- 49 installed in the US.
- Distribution
- Nationwide Distribution including the states of NJ, CO, LA, AL, OH, MA, NC, ME, WI, GA, PA, TX, IN, NY, MO, KY, KS, CA, MN, FL and IL.
- Lot, serial or model codes
- Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1.
- 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