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U.S. Department of Health and Human Services

Class 2 Device Recall HiSpeed FX/I

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 Class 2 Device Recall HiSpeed FX/Isee related information
Date Initiated by FirmFebruary 01, 2010
Date PostedJanuary 04, 2011
Recall Status1 Terminated 3 on May 21, 2014
Recall NumberZ-0784-2011
Recall Event ID 56400
Product Classification Computed Tomography X-Ray System - Product Code JAK
ProductHiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2)
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
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
ActionImportant 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 Commerce102 total
DistributionNationwide Distribution
Total Product Life CycleTPLC 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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