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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENDEX CORP. GENDEX VIXWIN¿ IMAGING SOFTWARE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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GENDEX CORP. GENDEX VIXWIN¿ IMAGING SOFTWARE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number VERSIONS 3.3 TO 3.4
Device Problems Problem with Software Installation (3013); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Event Description
Software vixwin was updated from version (b)(4).After the install, it was noted the upgrade caused how the images appear in the pacs imaging system which is our hospital's main system used to view imaging.This issue has caused the panorex to be inoperable and forcing medical staff to order other imaging to achieve the same result.
 
Event Description
Software vixwin was updated from version 3.3 to 3.4.After the install, it was noted the upgrade caused how the images appear in the pacs imaging system which is our hospital's main system used to view imaging.This issue has caused the panorex to be inoperable and forcing medical staff to order other imaging to achieve the same result.
 
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Brand Name
GENDEX VIXWIN¿ IMAGING SOFTWARE
Type of Device
SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
GENDEX CORP.
1910 n penn rd
hatfield PA 19440
MDR Report Key12744820
MDR Text Key279854296
Report Number12744820
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVERSIONS 3.3 TO 3.4
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/01/2021
Event Location Hospital
Date Report to Manufacturer11/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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