Date Initiated by Firm | February 06, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on November 23, 2005 |
Recall Number | Z-0282-04 |
Recall Event ID |
28191 |
PMA Number | P990066 |
Product Classification |
System, X-Ray, Mammographic - Product Code IZH
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Product | Seneographe 2000D Digital Mammography X-Ray System |
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
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Total Product Life Cycle | TPLC Device Report |
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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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