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U.S. Department of Health and Human Services

Class 2 Device Recall GE SENOGRAPHE ESSENTIAL

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 Class 2 Recall
GE SENOGRAPHE ESSENTIAL
see related information
Date Posted March 18, 2011
Recall Status1 Terminated on May 16, 2012
Recall Number Z-1041-2011
Recall Event ID 57784
Product Classification Full Field Digital,System,X-Ray,Mammographic - Product Code MUE
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.
Code Information All associated serial numbers.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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