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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) IT3500 RADIOLOGICAL IMAGE PROCESSING

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GE OEC MEDICAL SYSTEMS (SLC) IT3500 RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number IT3500
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
A ge service representative performed an onsite investigation. The computer was evaluated and replaced. The system was tested and found to be working as intended and returned to service.
 
Event Description
It was reported that the system failed to boot up. No patient serious injury or death was reported related to this event.
 
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Brand NameIT3500
Type of DeviceRADIOLOGICAL IMAGE PROCESSING
Manufacturer (Section D)
GE OEC MEDICAL SYSTEMS (SLC)
384 wright brothers drive
salt lake city UT
Manufacturer Contact
384 wright brothers drive
salt lake city, UT 
MDR Report Key6323306
MDR Text Key67174210
Report Number1720753-2017-00445
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIT3500
Device Lot NumberIT35409G
Other Device ID NumberNOT APPLICABLE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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