GE OEC 9900 Elite, OEC 9900 EliteMD, OEC 9900 EliteNAV, OEC 9800, OEC FluoroTrak 9800 Plus User manual

GE Healthcare

GE Healthcare, Surgery

384 Wright Brothers Drive

Salt Lake City, Utah 84116

Certified Mail Return Receipt Requested

URGENT RECALL NOTICE

PLEASE TAKE ACTION TO INFORM ALL USERS OF THE RELEVANT SYSTEM(S) OF

THESE ISSUES AND HOW TO ADDRESS THEM

February 22, 2008
To:	Hospital Administrator
	Director/Manager of Radiology
Subject:	Product Safety Issues:
	Vertical Lift Column Failure (PS3 Power Supply failure)

Affected Products: OEC® 9900 Elite, OEC®, 9900 EliteMD Motorized C-arm System, OEC® 9900 EliteNAV , OEC® 9800, OEC® FluoroTrak 9800 Plus, OEC® 9800 Plus, OEC® 9800MD Motorized C-arm System, OEC® 8800 Flexiview

Our records indicate that your facility has one or more of the following GEHC OEC products:

•OEC® 9900 Elite

•OEC® 9900 EliteMD Motorized C-arm System

•OEC® 9900 EliteNAV

•OEC® 9800

•OEC® FluoroTrak 9800 Plus

•OEC® 9800 Plus

•OEC® 9800MD Motorized C-arm System

•OEC® 8800 Flexiview

GE Healthcare has received reports from some customers of the vertical lift function of the C portion of the device failing on the above listed products. Failure of this functionality could result in the user experiencing difficulty in positioning the device.

Interim Solution:

To reduce the potential occurrence of this issue, users are advised to avoid activating both the up and down directional movement buttons on the mainframe at the same time. Should the user note that the vertical lift is slow to respond, or intermittently fails to respond to an up or down command, the user should contact the OEC Service Department at GEHC Surgery for a replacement of the failing power supply (PS3).

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