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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 Device Recall GE SENOGRAPHE ESSENTIAL see related information
Date Initiated by Firm July 20, 2010
Date Posted March 17, 2011
Recall Status1 Terminated 3 on May 16, 2012
Recall Number Z-1043-2011
Recall Event ID 57763
Product Classification Full Field Digital Mammographic System X-Ray - Product Code MUE
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.
Code Information All associated serial numbers.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer 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 Determined
Cause 2		 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
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.
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