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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 the customer's allegation. When additional information becomes available, a supplemental report shall 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 x-ray images were blurry. Due to images not presenting as expected, there is a potential for a delay in treatment or diagnosis which may lead to harm. There is no indication of a delay in treatment or diagnosis or harm that has occurred as a result of this issue. Reference complaint number (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 Key5815329
MDR Text Key50200241
Report Number2183926-2016-00655
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 Received07/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
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 Received06/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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