GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800 User manual

GE Healthcare

Pete McCabe

President and CEO
GE Healthcare, Surgery
384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
[e-mail]

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

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Pete McCabe

President and CEO
GE Healthcare, Surgery

384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
[e-mail]

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 2800
 OEC 9800 Plus Digital

 OEC 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.

DOC0287403

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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

DOC0287403

Page 2 of 2

IMPORTANT RADIATION SAFETY NOTICE – 9900 PRODUCT

GE Healthcare

OEC Medical Systems, Inc.

384 Wright Bros. Drive

Salt Lake City, Utah 84116

Phone: [phone]

Fax: [phone]

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).

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

4. If 30 PPS is displayed PLEASE IMMEDIATELY DISCONTINUE any use of the High Level Fluoro

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,

The user cannot select it.

set to 30 PPS.

Pulsed mode and contact your service team at 800-874-7378 for a priority service visit to correct
this problem.

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

Certified Mail Return Receipt Requested

GE Healthcare

Pete McCabe

President and CEO
GE Healthcare, Surgery
384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
[e-mail]

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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