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
Important Electronic Product Radiation Warning
PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVANT SYSTEM(S) OF
THESE ISSUES AND HOW TO ADDRESS THEM
June 12, 2007
To: |
Hospital Administrator |
|
Director/Manager of Radiology |
Subject: |
Product Safety Issues |
Affected Products: OEC ® 9900 Elite
OEC ® 9800
OEC ® 8800
OEC ® 6800
OEC ® 2800
Our records indicate that your facility currently has one or more of the products listed above.
GE Healthcare has identified an issue affecting these products as described below. This communication is intended to provide clarification on the prior communication dated April 2, 2007.
Failure to display Air Kerma and Cumulative Air Kerma:
A configuration issue has been discovered that results in the failure of the system to display the International Standard quantity, air kerma, to describe the radiation output. The usage of Air Kerma to replace entrance exposure, and the display of Air Kerma Rate and Cumulative Air Kerma are required on systems manufactured after June 10, 2006 by 21 CFR 1020.32(k). In GE OEC systems, AKR (air kerma rate) is calculated from technique factors (kVp, mA, and if pulsing, the duty factor.) CAK (cumulative air kerma) is calculated from the same, but accumulated over the duration of the procedure.
These systems, as shipped, did not meet the requirement of 21 CFR 1020.32(k), in that the systems were not configured to display Air Kerma Rate and Cumulative Air Kerma at the operators working position on individually distinguishable displays.
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This issue does not impact the safety of operation of your system, however does result in noncompliance to 21CFR 1020.32 (k).
Your GEHC Surgery service representative will be contacting you in the near future to arrange for an inspection and to modify your system configuration if necessary to assure compliance with the requirements of 21 CFR 1020.32(k) at no charge.
If you have any questions or concerns regarding these issues, please do not hesitate to contact the GEHC OEC service team for further information at 800-874-7378 option 8. Information is available at this number 24 hours per day, 7 days a week.
Thank you,
Pete McCabe
President and CEO
Page 2 of 2
GE Healthcare
Pete McCabe
President and CEO
GE Healthcare, Surgery
384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
Pete.mccabe@med.ge.com
Certified Mail Return Receipt Requested
URGENT RECALL NOTICE
PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVENT SYSTEM(S) OF
THESE ISSUES AND HOW TO ADDRESS THEM
February 21 2007 |
|
To: |
Hospital Administrator |
|
Director/Manager of Radiology |
Subject: |
Product Safety Issues |
Affected Products: |
OEC UroView 2800, OEC 9800 Plus Digital, OEC MiniView 6800, OEC |
|
FlexiView 8800 Mobile C-Arm |
Our records indicate that your facility has one or more of the following GE Healthcare OEC (GEHC OEC) devices that has received a replacement hard disk drive:
OEC UroView 2800OEC 9800 Plus DigitalOEC MiniView 6800
OEC FlexiView 8800 Mobile C-Arm
GEHC OEC has discovered an issue with the hard disk drives that were installed on the above listed products during service calls. The manufacture dates of the affected hard disk drives are between October 15, 2004 and December 8, 2004
This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400 images. Systems may also fail to boot or lose patient data as this image capacity is approached.
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DOC0287403
Your GEHC OEC Field Service Engineer will be contacting your facility to arrange to have a replacement hard disk drive installed on your system.
Until a GEHC OEC Field Service Engineer has replaced the hard disk drive users should ensure that images on the hard disk drive are stored via an alternate permanent media (film, long term storage) as the hard disk drive approaches the 170 image capacity.
GEHC OEC is actively working to replace the affected hard disk drives in a timely manner. GEHC OEC will, without charge, remedy this issue.
If you have any questions or concerns regarding these issues, please do not hesitate to contact the service team for further information at 800-874-7378 option 8. Information is available at this number 24 hours per day, 7 days a week.
Thank you,
Pete McCabe
President and CEO
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DOC0287403
IMPORTANT RADIATION SAFETY NOTICE – 9900 PRODUCT
GE Healthcare
OEC Medical Systems, Inc.
384 Wright Bros. Drive
Salt Lake City, Utah 84116
Phone: 801-328-9300
Fax: 801-328-4300
Date: August 14, 2006
To: |
Facility Administrator and Radiation Safety Officer |
GE Healthcare recently learned that your 9900 C-Arm might exceed the 20 R/minute limit required by the Code of Federal Regulations when in High Level Fluoro (HLF) Pulsed Mode and may pose a serious radiation hazard to both the patient and staff. This could occur if the Default Pulse Rate is set to 30 PPS on the 9900 C-Arm. Only a Field Service or Biomedical Engineer can manually change this value using RUS (Remote Utility Suite Software) or RUT (Remote Utility Tool). The user cannot select it.
At the time of this letter we have already initiated a mandatory system software upgrade for the 9900 product that is required for all systems manufactured prior to 5/19/06. This upgrade requires the new RUS software with the fix to prevent the Default Pulse Rate being set to 30 PPS. If your system has been upgraded the 30 PPS option cannot be selected. You can determine your software version by pressing the HELP Screen and looking at the WS NODE that should display 6.15.1 or 6.15.3. If your system has not been upgraded, please contact your GE service team at 800-874-7378 to schedule the upgrade.
In the meantime, you can do the following steps to determine if this issue affects your system:
1.Power the system up.
2.Press the PULSE button on the C-Arm
3.If 30 PPS is displayed in the status bar on the right workstation monitor, the Default Pulse Rate is set to 30 PPS.
4.If 30 PPS is displayed PLEASE IMMEDIATELY DISCONTINUE any use of the High Level Fluoro Pulsed mode and contact your service team at 800-874-7378 for a priority service visit to correct this problem.
If 30 PPS is NOT displayed, your system complies with the federal regulation and no further action is required
GE OEC will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan approved by the Secretary of Health and Human Services.
For Further information, please contact your service team at 800-874-7378.
Sincerely yours,
Kenneth F. Miles, PhD.
Vice President Regulatory Affairs and Quality Assurance
GE OEC Medical Systems, Inc.
General Electric Company |
FMI 15045 Int Ref No. 06-003 |
GE Healthcare
Pete McCabe
President and CEO
GE Healthcare, Surgery
384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
Pete.mccabe@med.ge.com
Certified Mail Return Receipt Requested
URGENT RECALL NOTICE
PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVENT SYSTEM(S) OF
THESE ISSUES AND HOW TO ADDRESS THEM
January 12, 2007 |
|
To: |
Director Surgery/Urology |
|
Director/Manager of Radiology |
Subject: |
Product Safety Issues |
Affected Products: OEC® UroView 2800 and OEC® UroView 2800 with Dual Monitor Option
Our records indicate that your facility has one or more OEC® UroView 2800 and/or OEC®
UroView 2800 with Dual Monitor Option
GE Healthcare has identified two (2) potential safety issues that may occur with the OEC® UroView 2800 product based upon feedback from some customers. The details of these issues, as well as the associated interim solutions, are outlined below.
1. Dual Monitor Safety Risk:
Affected Products: OEC® UroView 2800 Dual Monitor Configuration
There have been instances in which the dual monitor on a Uroview 2800 became disconnected from
the assembly arm. The dual monitor assembly arm on the Uroview 2800 could pose a safety risk to patients, users, or other personnel should the monitors become disconnected.
A small hardware component on your Uroview 2800 needs to be inspected and possibly modified to correct this potential safety risk. Your GEHC-OEC Field Service Engineer will be contacting your facility to inspect your Uroview 2800 to see if it is impacted by this potential risk. If your system is
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