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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 Recall
Infinia with Hawkeye 1
see related information
Date Posted January 21, 2010
Recall Status1 Terminated on February 04, 2012
Recall Number Z-0494-2010
Recall Event ID 53883
Product Classification System, X-Ray, Tomography, Computed - 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, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Failure to provide the complete User Manual information.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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