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IMPORTANT PRODUCT INFORMATION
<Date of Letter Deployment>
Hospital Administrators / Risk Managers
To:
Managers of Radiology / Cardiology
Radiologists/Cardiologists
RE:
Recommendations on the use of "One More" functionality in CT, PET-CT, and SPECT-CT Scanners
Please ensure that all potential users in your facility are made aware of this notification and the recommended actions.
Issue
GE Healthcare has been made aware of an event caused by the errant use of the "One More"
functionality during a CT examination in France. This function is available on all GE Healthcare CT,
PET-CT, and SPECT-CT equipment, except Revolution CT.
This event does not relate to a malfunction of the device and there is no product defect.
However, we are sending this notice to provide additional recommendations on the use of the
"One More" function.
Following the installation of a CT, PET-CT, or SPECT-CT system, the users designated by the
Instructions
site are trained by GE application engineers to use the equipment, including the "One More"
functionality. It is recommended that only duly trained and qualified personnel be allowed
to use the system.
To provide you additional guidance on use of the "One More" function we have included an
operator manual addendum along with this letter.
Additionally, an online training tutorial on the "One More" function is available via the
following links:
Quick Reference Guide - CT One More function (English, Danish, Finnish, Swedish)
Link:
https://www.gecares.com/GEHealthCare/GEHCArticle?id=aBU0c00000004kuGAA
Our application engineers are also available to provide additional training on this tool should
users at your site need it.
Please also note that most of the affected GE Healthcare CT, PET-CT, and SPECT-CT systems
are equipped with "Dose Check", a dosimetry control tool that allows physicists and
radiologists to establish dose thresholds based on their practice. The feature informs
operators of CT devices when scan settings would likely exceed pre-assigned dose
thresholds based on their practice.
Dose Check provides the following:
•
Checking against a Notification Value if the estimated dose for the scan is above your
site typical dose value
•
Checking against an Alert Value where the user needs specific authority to continue
the scan at the current estimated dose without changing the scan parameters.
•
Defining Alert Values for Adult and Pediatric with age threshold
•
Audit logging and review
•
Protocol Change Control
It is strongly recommended that all users enable the "Dose Check" control feature. GE
GE Healthcare
3000 N. Grandview Blvd. - W440
Waukesha, WI 53188, USA
GEHC Ref# 26861
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Summary of Contents for GE CT
- Page 1 Please ensure that all potential users in your facility are made aware of this notification and the recommended actions. Issue GE Healthcare has been made aware of an event caused by the errant use of the “One More” functionality during a CT examination in France. This function is available on all GE Healthcare CT, PET-CT, and SPECT-CT equipment, except Revolution CT.
- Page 2 Optima CT Series Discovery MI, MI-DR Discovery CT Series Revolution ACT, HD, GSI, If you have any questions or concerns regarding this notification, please contact GE Contact Healthcare Service at or your local Service Representative. Information 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 per the contact information above.