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  Class 2 Device Recall GE SENOGRAPHE ESSENTIAL see related information
Date Initiated by Firm January 19, 2011
Date Posted March 18, 2011
Recall Status1 Terminated 3 on May 16, 2012
Recall Number Z-1041-2011
Recall Event ID 57784
Product Classification Full Field Digital Mammographic X-Ray System - Product Code MUE

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.
Code Information All associated serial numbers.
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer 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).
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.