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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500 RADIOLOGICAL IMAGE PROCESSING

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GE OEC MEDICAL SYSTEMS (SLC) ITRAK 3500 RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ITRAK 3500
Device Problem Device Inoperable
Event Date 05/02/2016
Event Type  Malfunction  
Manufacturer Narrative

A ge service representative performed an over the phone investigation. The system database was rebuilt with assistance from the user. The reported problem was resolved by the customer. No additional service information was provided.

 
Event Description

The customer reported that the system failed to boot. No patient serious injury or death was reported related to this event.

 
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Brand NameITRAK 3500
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 
MDR Report Key5668075
Report Number1720753-2016-01283
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/19/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberITRAK 3500
Device LOT NumberIT35188P
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 Received05/02/2016
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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