Date Initiated by Firm | August 01, 2009 |
Date Posted | January 21, 2010 |
Recall Status1 |
Terminated 3 on February 04, 2012 |
Recall Number | Z-0495-2010 |
Recall Event ID |
53883 |
Product Classification |
Computed Tomography X-Ray System - Product Code JAK
|
Product | Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118.
Generating head and whole body CT images of human subjects |
Code Information |
All serial numbers associated with model numbers H3000WC and H3000WD. |
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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