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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING

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GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ENTRAK 2500
Device Problem Device Inoperable
Event Date 07/30/2015
Event Type  Malfunction  
Manufacturer Narrative

A ge service representative performed an on site investigation. The connectors were reseated and the software was installed during the service call. The system was tested and found to be working as intended and put back into service.

 
Event Description

The customer reported that the system failed to boot. There was no patient injury or death reported.

 
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Brand NameENTRAK 2500
Type of DeviceRADIOLOGICAL IMAGE PROCESSING
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 Key5025455
Report Number1720753-2015-03381
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/24/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberENTRAK 2500
Device LOT NumberIT25081
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 Received07/30/2015
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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