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U.S. Department of Health and Human Services

Class 2 Device Recall Infinia with Hawkeye 1

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  Class 2 Device Recall Infinia with Hawkeye 1 see related information
Date Initiated by Firm August 01, 2009
Date Posted January 21, 2010
Recall Status1 Terminated 3 on February 04, 2012
Recall Number Z-0494-2010
Recall Event ID 53883
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. GE Healthcare, Waukesha, Wisconsin 53118.

Generating head and whole body CT images of human subjects
Code Information All serial numbers associated with model numbers H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS.
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
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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