GE Healthcare
Pete McCabe
President and CEO
GE Healthcare, Surgery 384 Wright Brothers Drive Salt Lake City, Utah 84116 U.S.A.
Pete.mccabe@ ge.com
Certified Mail Return Receipt Requested
IMPORTANTELECTRONIC PRODUCT RADIATION
WARNING
PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVENT SYSTEM(S) OF
THESE ISSUES AND HOW TO ADDRESS THEM
July 11, 2007 |
|
To: |
Hospital Administrator |
|
Director/Manager of Radiology |
Subject: |
Product Compliance Issue |
Affected Products: GEHC OEC 9900 ESP-15 Elite C-Arm
GEHC OEC 9800 ESP-15 C-Arm
Our records indicate that your facility currently has one of the devices listed above. GE Healthcare has identified an issue affecting these devices
The details and symptom of the issue, as well as the associated solution is outlined below.
Air Kerma Rate Display Exceeds Allowable Error:
During internal testing GEHC Surgery has discovered that an issue in the displayed values of Air Kerma Rate such that cumulative air kerma could exceed the allowable 35% as specified in 21 CFR 1020.32(k)(6) under certain imaging conditions. Specifically, this error in the displayed value can exceed the allowable 35% when the system is operated at 15 pulses per second, in manual exposure rate control mode when extreme selections of high kVp values and low mA values are made in combination.
The accuracy of the displayed values of Air Kerma Rate and cumulative air kerma in all automatic exposure rate control modes and manual exposure rate control modes, both in continuous and pulsed operation is compliant otherwise. This issue does not impact the safety of operation of your system, however may result in non-compliance to 21CFR 1020.32 (k)(6).
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