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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare STe (16 slice) System

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  Class 2 Device Recall GE Healthcare STe (16 slice) System see related information
Date Initiated by Firm October 27, 2010
Date Posted February 07, 2011
Recall Status1 Terminated 3 on July 13, 2012
Recall Number Z-0944-2011
Recall Event ID 57193
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010.

Head and whole body X-ray computed tomography applications.
Code Information Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer Reason
for Recall
Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual (TRM) are incorrect. CTDI100 Aperture Adjustment Factors for 4x0.625 mode contain incorrect values. This issue may lead to inaccurate CTDI manual calculation. The results of the diffe
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.
Quantity in Commerce 1450 units total in US
Distribution Worldwide Distribution
Total Product Life Cycle TPLC 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.