Reported Feb 24, 2016 · Terminated
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse…
Varian Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6
- Model numberH48
- Product UsageThe Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments
- Lot codes and dates
- ModelH48:
- Serial numbers
4,039 of 4,039 codes
H480110H48C045H488552H480119H487642H480345H480409H480541H480814H48D577H481205H48D125H48I971H488466H48A830H48G592H48L819H480267H48C046H488553H480123H48B153H480348H489828H480542H480819H48D580H481206H48D126H48I972H489917H48K547H48G593H48L823H480268H48K563H48I901H480124H48B154H480349H48E077H480566H480820H48I607H481262H48E255H48I973H48A912H481952H486308H48J014H482174H48L882H48I790H480126H48F494H480350H487078H480590H480821
- Amount recalled
- 9499
Where it was sold
Why it was recalled
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
This product could cause temporary or reversible health problems — stop using it.
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