Recall record at a glance
| Official record | Z-1803-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Viewray, Inc. |
| Report date | May 6, 2020 |
| Recall initiation date | Nov 18, 2019 |
| Quantity | 32 |
| Location | Mountain View, CA, United States |
Official product description
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Why the product 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.
Distribution information
Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to them and they forwarded them to the sites.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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