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U.S. Department of Health and Human Services

Class 2 Device Recall General Electric Seneographe

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  Class 2 Device Recall General Electric Seneographe see related information
Date Initiated by Firm February 06, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 23, 2005
Recall Number Z-0287-04
Recall Event ID 28191
510(K)Number K881882  
Product Classification System, X-Ray, Mammographic - Product Code IZH
Product Seneographe 600 Mammography X-Ray Systems (all versions)
Code Information All serial numbers
Recalling Firm/
Manufacturer		 General Electric Med Systems
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Larry A. Kroger
262-544-3894
Manufacturer Reason
for Recall		 The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
FDA Determined
Cause 2		 Other
Action The consignees were sent 'Regulatory Notice' letters dated February 6, 2004. The letters informed the consignees of the violations and provided them with the technical specifications which needed to be provided.
Distribution Nationwide in the United States
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.
510(K) Database 510(K)s with Product Code = IZH and Original Applicant = GENERAL ELECTRIC CO.
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