GE Healthcare
GE Healthcare, Surgery
384 Wright Brothers Drive
Salt Lake City, Utah 84116
U.S.A.
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
January 23, 2008
To: |
Director/Manager of Radiology |
|
Facility Administrator |
Subject: |
Product Safety Issues |
Affected Products: OEC® InstaTrak 3500 Plus FluoroTrak and FluoroCAT spinal applications used with Regular and Super C 9800 and 9600 C Arm systems and OEC® FluoroTrak 9800 C-arms
Our records indicate that your facility has one or more of the following GEHC OEC products:
•OEC® InstaTrak 3500 Plus Fluoro Trak and Fluoro CAT Spinal Applications used with Regular and Super C 9800 and 9600 C-arm Systems or OEC® FLuoroTrak 9800 C-arm.
GE Healthcare Surgery has identified a potential safety issue with the systems listed above.
If your facility is receiving this notification, our records indicate that your OEC® InstaTrak 3500 Plus or 9800 FluorTrak may be affected by this issue.
GEHC Surgery has identified through internal testing, issues that could impact the overall accuracy of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus system when used with either the 9" Regular C Arm or the “Super C” C Arm. This issue could result in an injury to the patient due to incorrect anatomical location of an instrument during a procedure.
Interim Solution:
Users are advised to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus system.
Page 1 of 2
Loading...