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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 Device Remains Activated (1525)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2014
Event Type  malfunction  
Event Description
The customer reported that x-rays stay on after releasing the x-ray switch.No patient serious injury or death was reported related to this event.
 
Manufacturer Narrative
A ge service representative performed an on site investigation.The reported issue could not be duplicated.Onsite investigation revealed that no cause could be determined.A defective footswitch was identified and replaced during the service event.The system was tested and found to be working as intended and returned to 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 dr.
salt lake city UT 84116
Manufacturer (Section G)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers dr.
salt lake city UT 84116
Manufacturer Contact
384 wright brothers dr.
salt lake city, UT 84116
8015364952
MDR Report Key3928623
MDR Text Key4670672
Report Number1720753-2014-04907
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9600
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/21/2014
Was Device Evaluated by Manufacturer? Yes
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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