Reported May 6, 2020 · Terminated
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and…
Viewray, 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: Viewray, Inc. · 815 E Middlefield Rd · Mountain View, CA · 94043-4025
Is this the product you have?
- ViewRay SystemModel No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
- Lot codes and dates
- Model No.10000 -
- Serial No's
100104105112113 Model No. 20000 -
- Serial No's
101102107108200201203204206207209211213214215216217218221223225227228232238240243244247250
- Amount recalled
- 32
Where it was sold
Why it was recalled
Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
This product could cause temporary or reversible health problems — stop using it.
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