| Class 2 Device Recall HiSpeed LXI | |
Date Initiated by Firm | February 01, 2010 |
Date Posted | January 04, 2011 |
Recall Status1 |
Terminated 3 on May 21, 2014 |
Recall Number | Z-0744-2011 |
Recall Event ID |
56400 |
Product Classification |
Computed Tomography X-Ray System - Product Code JAK
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Product | HiSpeed LXI (2200997) |
Code Information |
With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2. |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-513-4122 |
Manufacturer Reason for Recall | A defect with the hardware and software displaying the incorrect dose data. |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter. |
Quantity in Commerce | 102 total in US |
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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