Z-1043-2011

GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is...

Name: Z-1043-2011 GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is...
Creator: GE Healthcare, LLC
Published: 2010-07-20
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-07-20 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is for the same clinical applications as traditional... on 2010-07-20. The reason FDA records is "It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1043-2011
Status: Terminated
Initiated: 2010-07-20
Posted: 2011-03-17
Terminated: 2012-05-16
Recalling firm: GE Healthcare
Product: GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is for the same clinical applications as traditional mammographic film/screen systems. It generates 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: It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate.
FDA root cause: Radiation Control for Health and Safety Act
Action: An Important Electronic Product Radiation Warning letter was issued to customers identifying the affected product and describing the defect along with the related hazards. The letter states that there are no actions that are required to be taken on the part of the customer. A GE Healthcare Service Representative will apply the missing rating as necessary and free of charge. Questions or concerns regarding the letter should be directed to 1-800-437-1171 in the US.
Quantity in commerce: 112 total
Distribution: Worldwide 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)