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U.S. Department of Health and Human Services

Class 2 Device Recall HiSpeed X/i Computed Tomography

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 Class 2 Recall
HiSpeed X/i Computed Tomography
see related information
Date Posted December 17, 2010
Recall Status1 Terminated on May 16, 2012
Recall Number Z-0007-2011
Recall Event ID 54154
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Code Information Console Serial Numbers: 074639HM6, 659297YM6, 695155YM2, 730392YM8, 777756YM8, 789223YM5, 818161YM2, 836965YM4, 836971YM2, 864568YM 1, 869641 YM 1, 530941YM4, 594144YM8, 659292YM7, 678189YM2, 65931 1YM5, 696890YM3, 530873YM9, 659208YM3, 730349YM8, 544504YM4, 766560YM7, 766630YM8, 856398YM3, 474793YM7, 530946YM3, 874664YM6, 813279YM7, 839995YM8, 854095YM7, 869512YM4, 766587YMO, 887561YM9, 840000YM4, 813261 YM5, 717723YM1, 717727YM2, 877979YM5, 808479YMO, 812782YM1, 659200YMO, 766610OYMO, 877971YM2, 730393YM6, and 865531YM8.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action GE Healthcare will bring customer systems into compliance with 21 CFR by having a GE Healthcare field service representative, who will perform a field corrective action, visit each customer site. This will be carried out via a Field Modification Instruction planned to be released in October 2009 and planned to be completed by February 2010. Additionally, all forward production operator consoles are manufactured so as to comply with 21 CFR and to include a manufacturing check for appropriate labeling.
Quantity in Commerce 45 units (13 Nationwide)
Distribution Worldwide Distribution -- USA, including states of ME, FL, IA, AL, CT, CA, TX, KS, KY, OH, and WV and countries of Japan, Russian Federation, India, Argentina, Brazil, Italy, Poland, Puerto Rico, Romania, and Saudi Arabia.
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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