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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING

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ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING Back to Search Results
Model Number ENTRAK 2500
Device Problem Device Inoperable
Event Date 06/08/2015
Event Type  Malfunction  
Event Description

The customer reported that the system failed to boot and exhibited a non-recoverable loss of functionality. No patient serious injury or death was reported related to this event.

 
Manufacturer Narrative

A ge service representative performed an over the phone investigation. System file corruption was identified as the cause of the event. The reported problem was resolved by the customer with assistance from the engineer. No additional service information was provided.

 
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Brand NameENTRAK 2500
Type of DeviceRADIOLOGICAL IMAGE PROCESSING
Manufacturer Contact
384 wright brothers dr.
salt lake city , UT 84116
8015364952
MDR Report Key4890833
Report Number1720753-2015-02631
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberENTRAK 2500
Device LOT NumberIT25047
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/08/2015
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

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