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Author Topic: GE Warning: URGENT MEDICAL DEVICE CORRECTION  (Read 10724 times)
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Eric_R
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« on: March 21, 2010, 08:56:57 AM »

Here is a warning from GE about the problem of 3D reconstruction of CT (or any modality) images that have been taken in a prone position (lying face down).

URGENT MEDICAL DEVICE CORRECTION

March 1, 2010

To: Director/Manager of Radiology Hospital Administrator
Head of Radiology Department PACS Administrator   

RE: GE CentricityTM PACS-IW; Software Versions: 3.x

GE Healthcare has recently become aware of a potential safety issue associated with the use of GE Centricity PACS-IW software related to the use of built-in reconstruction functions.
Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions.

Safety Issue
Use of built-in reconstruction functions may result in incorrect anatomic orientation marker.

Details:
When cross-sectional (CT, MR, PET-CT) studies are acquired in the prone position, and reconstruction is performed using built-in functions, the reconstructed image will display anatomic orientation markers incorrectly. This problem will also occur if the source series is manually rotated or mirrored by the user at the time the study is read, and then reconstruction is performed.

Built-in reconstruction functions are used in a number of internal PACS-IW image manipulation functions, specifically, built-in MIP/MPR (beginning with version 3.31, Slab Scroll, Fusion, Angio (beginning with version 3.5), and Advanced PET-CT (beginning with version 3.71.

Affected Product Details
GE Centricity PACS-IW: Software Versions: 3.x

Safety Instructions
Always confirm image side and site annotation markers at the time of image review and interpretation. Pay special attention to the orientation of reconstructed images as compared to the original series.

Under the following 2 conditions, it's recommended that you avoid using built-in MIP/MPR, Slab Scroll, or Fusion operations on the series unless special attention is paid to the placement of orientation markers:
   Images are displayed prone or decubitus left/right; OR
   Images have been manually flipped, mirrored or rotated;
 
    If you use the Advanced PET/CT module, it's recommended that you avoid using Advanced PET-CT hanging protocols for studies acquired in prone or decubitus positions.

Do not use Angio operation on CT or MR series.

Do not use integrated Voxar and Traumacad on series that have been manually flipped, mirrored or rotated.

Product Correction
A permanent product correction (in the form of a software update) will be provided to you to address the above issue.

Until the permanent product correction is made available, please follow the safety instructions above.

If you have questions
Please contact your local PACS-IW sales executive or GE Healthcare at IW_Questions@ae.com or contact your Remote Online Center (ROC), Customer Care Center at:

Americas: 1-800-437-1171

EMEA: +33 1 30 83 13 00

Asia:

        Singapore - 63880932
        Malaysia - 1800883911
        Australia - 1800659465
        New Zealand - 0800659465
        India - 1800114567
        Korea - 15446119
        Japan - 0120055919
        Taiwan - 0800021770
        China - 8008108188
        Hong Kong - 852-21006288

Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately.
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Eric_R
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« Reply #1 on: October 13, 2010, 06:51:56 AM »

GE / Dynamic Imaging have released a notice that their latest version of software can now correct this problem and they encourage all Centricity Web IW (Integrad) users to upgrade.

This may require a hardware upgrade for those using older versions of the software.
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