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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. ECLIPSE TREATMENT PLANNING SYSTEM; ECLIPSE, TREATMENT PLANNING SYSTEM
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VARIAN MEDICAL SYSTEMS, INC. ECLIPSE TREATMENT PLANNING SYSTEM; ECLIPSE, TREATMENT PLANNING SYSTEM Back to Search Results
Model Number H48
Device Problems Application Program Problem: Dose Calculation Error (1189); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2015
Event Type  malfunction  
Manufacturer Narrative
Investigation has revealed that pbc 11.0.31 calculates wrong dose for any arc field when the number of dose calculation control points exceeds 100.(b)(4).
 
Event Description
Customer reported that they are not able to calculate full conformal arc with eclipse using pbc v11.Calculation results with monitor units = 0 for conformal arc with span bigger than 234 degrees or 118 control points.No patient injury has been reported.
 
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Brand Name
ECLIPSE TREATMENT PLANNING SYSTEM
Type of Device
ECLIPSE, TREATMENT PLANNING SYSTEM
Manufacturer (Section D)
VARIAN MEDICAL SYSTEMS, INC.
911 hansen way
palo alto CA 94304 1028
Manufacturer (Section G)
VARIAN MEDICAL SYSTEMS FINLAND OY
paciuksenkatu 21
helsinki, 00270
FI   00270
Manufacturer Contact
k. semone
911 hansen way
palo alto, CA 94304-1028
6504246833
MDR Report Key5316026
MDR Text Key34041281
Report Number3003793371-2015-00002
Device Sequence Number1
Product Code MUJ
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K102011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberH48
Device Lot NumberVERSION 13.5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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