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Class 2 Device Recall HiSpeed X/i Computed Tomography |
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Date Initiated by Firm |
May 01, 2009 |
Date Posted |
December 17, 2010 |
Recall Status1 |
Terminated 3 on May 16, 2012 |
Recall Number |
Z-0007-2011 |
Recall Event ID |
54154 |
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Product Classification |
Computed Tomography X-Ray System - Product Code JAK
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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 WI 53188-1615
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For Additional Information Contact |
262-544-3894
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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.
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FDA Determined Cause 2 |
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
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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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