OEC Medical Systems, Inc Recalls
Showing 1-8 of 8 recalls
GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
Under certain conditions, x-ray system may experience operational impairment.
Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.
GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.
Beam limitation may be non-compliant on some X-ray units.
Consignees were notified by letter on 08/12/2008. GE service representatives will check proper beam compliance on next scheduled maintenance visit or will schedule a visit to address the issue. Information available at 1-800-874-7378.
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected.
GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.
OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
Use of existing four-pedal footswitch on a different machine may cause various operational errors.
Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.
ENTrak Navigation and Visualization System
Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
Customers were notified by letter on 12/13/04.
GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE
Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded.
Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.
No Premarket Notification: Product does not have FDA 510(k) approval for use.
Consignees were notified by an Urgent Recall Notice letter on 12/20/2007. The letter instructed users to stop using and to dispose of the recalled drapes. For additional information, contact 1-800-874-7378.
OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.
X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures
Consignees were notified by letter on 05/24/2007 and advised that a service representative would be contacting them for installation of the required label and to provide them with an update to their user's manuals.