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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9600; FLUOROSCOPIC X-RAY
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GE OEC MEDICAL SYSTEMS (SLC) 9600; FLUOROSCOPIC X-RAY Back to Search Results
Model Number 9600
Device Problem Failure to Power Up (1476)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/08/2015
Event Type  malfunction  
Event Description
The customer reported the system had a collimator iris pot error and would not boot up.There was no patient injury or death reported.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The collimator potentiometer was replaced and the collimator was calibrated during the service call.The system was tested and found to be working as intended and put back into service.
 
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Brand Name
9600
Type of Device
FLUOROSCOPIC X-RAY
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT 84116
Manufacturer Contact
384 wright brothers drive
salt lake city, UT 84116
MDR Report Key4950654
MDR Text Key6192555
Report Number1720753-2015-03056
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9600
Device Lot Number69-2955
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/1997
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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