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U.S. Department of Health and Human Services

Class 2 Device Recall BrightSpeed Excel/Edge/Elite Select Computed Tomography XRay System

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  Class 2 Device Recall BrightSpeed Excel/Edge/Elite Select Computed Tomography XRay System see related information
Date Initiated by Firm May 01, 2010
Date Posted March 01, 2011
Recall Status1 Terminated 3 on December 05, 2013
Recall Number Z-0286-2011
Recall Event ID 56922
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System.

For head, whole body X-ray Computed Tomography applications.
Code Information Gantry model numbers 5191001, 5191002, 5191003, and 5191003-2.
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		 Failure to properly document the CTDI in the Technical Reference or User Manual.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will bring the Technical Reference Manual into compliance by correcting the noncompliance in forward production and the installed base units. This will be accomplished by delivering an "Important Electronic Product Radiation Warning" letter and a TRM addendum which contains the corrected information to customers. This will be carried out via a Field Modification Instruction IFMI 229251 planned to be released in October, 2010 with an estimated completion date of April, 2011. The letter identifies the affected product and describes the defect and related hazards. It also asks customers to refer to the TRM addendum for the scan time accuracy, the helical scan exposure time, and the CTDI adjustment factors for 4 and 8 slices. Contact information is also provided.
Quantity in Commerce 103 units
Distribution Nationwide 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.
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