Date Initiated by Firm |
August 01, 2009 |
Date Posted |
January 21, 2010 |
Recall Status1 |
Terminated 3 on February 04, 2012 |
Recall Number |
Z-0496-2010 |
Recall Event ID |
53883 |
Product Classification |
Computed Tomography X-Ray System - Product Code JAK
|
Product |
Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE Healthcare, Waukesha, Wisconsin 53118.
Generating head and whole body CT images of human subjects. |
Code Information |
All serial numbers associated with model number BR321000008. |
Recalling Firm/ Manufacturer |
GE Medical Systems, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact |
262-544-3894
|
Manufacturer Reason for Recall |
Failure to provide the complete User Manual
information.
|
FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
Action |
A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units. |
Quantity in Commerce |
343 total |
Distribution |
Nationwide Distribution |
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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