GE Healthcare
GE Healthcare, Surgery
384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
Certified Mail Return Receipt Requested
IMPORTANTELECTRONIC PRODUCT RADIATION
WARNING
PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVANT SYSTEM (S) OF
THESE ISSUES AND HOW TO ADDRESS THEM
October 17, 2007
To: |
Hospital Administrator |
|
Director/Manager of Radiology |
Affected Product: |
OEC® 9800 & OEC® 9900 Elite |
In a previous communication GE Healthcare informed customers that some 9800 and 9900 C-Arms might exceed the 20 R/minute limit required by the 21 CFR 1020.32 (d)(2)(iii)(C) when in High Level Fluoro (HLF) Pulsed Mode. This communication is intended to clarify the issue for our users.
The issue described above could occur if the Default Pulse Rate is set to 25 or 30 Pulses Per Second (PPS) on the 9800 or the 9900 C-Arm Workstation. Assemblers, installers, or service personnel can manually change this value using RUS (Remote Utility Suite Software) or RUT (Remote Utility Tool). The user cannot select it.
Please do the following to determine if this issue affects your system:
1.Power the system up
2.Press the PULSE button on the C-Arm
3.If 25 or 30 PPS is displayed in the status bar on the right workstation monitor, the Default Pulse Rate is set to 25 or 30 PPS
4.IF 25 OR 30 PPS IS DISPLAYED PLEASE USE THE INTERIM SOLUTION DESCRIBED BELOW
5.If 25 or 30 PPS is NOT displayed, your system complies with the Code of Federal Regulations, and no further action is indicated.
6.Test is complete. Shut down the system.
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