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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE, AN IBM COMPANY RADSUITE IMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ

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MERGE HEALTHCARE, AN IBM COMPANY RADSUITE IMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ Back to Search Results
Model Number RADSUITE V8.30.7.9
Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2016
Event Type  Malfunction  
Manufacturer Narrative

Merge healthcare is investigating this allegation by the customer. When additional information becomes available, a supplemental report will be submitted.

 
Event Description

Merge radsuite application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2d and reconstructed 3d radiological images using web-enabled viewers over both local and wide area networks. On (b)(6) 2016, merge healthcare support received a customer allegation indicating that they "cant invert image when using window level tool on one study". With images not being presented as expected to a user, there is a potential for a delay in treatment or diagnosis which may lead to harm. There have been no reports of delay in treatment or diagnosis to a patient or of harm as a result of this issue. (b)(4).

 
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Brand NameRADSUITE
Type of DeviceIMAGE PROCESSING SYSTEM, PRODUCT CODE: LLZ
Manufacturer (Section D)
MERGE HEALTHCARE, AN IBM COMPANY
900 walnut ridge drive
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE
900 walnut ridge drive
hartland WI 53029
Manufacturer Contact
meg mucha
900 walnut ridge drive
hartland, WI 53029
2629123570
MDR Report Key5814483
MDR Text Key50187877
Report Number2183926-2016-00659
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK053281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberRADSUITE V8.30.7.9
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/07/2016
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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