Z-1041-2011

GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is...

Name: Z-1041-2011 GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is...
Creator: GE Healthcare, LLC
Published: 2011-01-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-01-19 / Terminated / root cause: labeling and UDI

FDA source

GE Healthcare, LLC began a recall of GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is intended to be used in the same clinical applications... on 2011-01-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1041-2011
Status: Terminated
Initiated: 2011-01-19
Posted: 2011-03-18
Terminated: 2012-05-16
Recalling firm: GE Healthcare
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.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 14
Distribution: Nationwide Distribution
Product codes and lots: All associated serial numbers.

Product code MUE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)