Z-1519-2013Class II

GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images...

Name: Z-1519-2013 GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images...
Creator: GE Healthcare, LLC
Published: 2013-01-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-01-14 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the... on 2013-01-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1519-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Posted: 2013-06-26
Terminated: 2013-11-26
Recalling firm: GE Healthcare
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.
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: Models 5144816-10 rev 2, 3 or 6 and 5144816-10-LE rev1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1519-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1519-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-26

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)